The patient does not meet the exclusion criterion regarding the use of systemic corticosteroids exceeding the allowed dose.
Provision of signed and dated informed consent form.
Provision of informed consent is a future action, so eligibility cannot be determined.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Willingness to comply with study procedures is a future action, so eligibility cannot be determined.
Male or female aged 18 years or older.
The patient is a 68-year-old male, meeting the age and gender requirement.
References:
Participants must have histologically or cytologically confirmed non-small cell lung cancer which is stage IV.
The patient has a confirmed diagnosis of stage IV non-small cell lung cancer.
References:
Participants should not have a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists in first line (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations).
There is no information on known sensitizing mutations for which an FDA-approved targeted therapy exists.
Participants should not have received prior systemic anticancer therapy for advanced or metastatic disease. For patients who are recently diagnosed and received one cycle of chemotherapy while awaiting NGS/PDL-1 testing are allowed on study after discussion with medical monitor.
The patient has not received prior systemic anticancer therapy for advanced or metastatic disease.
References:
Participants should have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
There is no information on measurable disease based on RECIST 1.1.
Participants should have a life expectancy of at least 3 months.
There is no information on the patient's life expectancy.
Participants should have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
The patient's performance status is not explicitly mentioned, but he is able to perform daily activities with some assistance.
Participants should have provided tumor tissue from locations not radiated prior to biopsy; fresh formalin fixed specimens or archival samples which have been determined as PD-L1 status <1% or negative prior to randomization.
There is no information on tumor tissue biopsy and PD-L1 status.
Participants should have been evaluated for circulating tumor DNA at baseline which has been determined to be detected, present or positive.
There is no information on circulating tumor DNA evaluation.
Participants with CNS metastases are eligible if all metastases have been treated and have remained stable without growth for at least 2 weeks post-treatment, the participant's neurological status has returned to baseline or remained stable for at least 2 weeks, and any use of corticosteroids for CNS metastases is at a dose of ≤10 mg daily prednisone (or an equivalent dose of another corticosteroid) and has been stable for at least 2 weeks before enrollment.
There is no information on CNS metastases or related treatment.
Participants should have adequate organ function to be able to safely receive the approved standard of care regimens per the current FDA approved package insert, treating investigators discretion and institutional guidelines.
There is no information on the patient's organ function.
For females of reproductive potential: Negative urine and serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, serum pregnancy test will be required. Participants should be willing to use an adequate method of contraception for the course of the study through 120 days after last dose of study medication or through 180 days after last dose of chemotherapeutic agents. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
The patient is male, so this criterion is not applicable.
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
There is no information on the use of contraception methods.
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks prior to administration of study regimen.
The patient is not currently participating in another study or receiving study therapy.
References:
Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
The patient received a seasonal flu vaccine two weeks ago, which is permitted.
References:
Has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis.
There is no information on diverticulitis, intra-abdominal abscess, GI obstruction, or abdominal carcinomatosis.
Prior treatment or history of allergy/hypersensitivity with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other specific T-cell co-stimulation or checkpoint targeting drugs.
The patient has not received prior immunotherapy treatments.
References:
Has a known sensitivity to any component of cisplatin, carboplatin, paclitaxel or pemetrexed.
The patient denies any history of allergies to medications.
References:
Participants with carcinomatous meningitis.
There is no information on carcinomatous meningitis.
Participants with active or suspected autoimmune diseases are excluded, with the following exceptions allowed: vitiligo, well-controlled type I diabetes mellitus, residual hypothyroidism due to autoimmune condition requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
There is no information on active or suspected autoimmune diseases.
Individuals who have received systemic corticosteroids or other immunosuppressive medications within the last 14 days prior to enrollment are excluded. Exceptions are made for topical, inhaled, nasal, ophthalmic steroids, or systemic corticosteroids at physiological doses not to exceed 10 mg/day of prednisone or an equivalent corticosteroid.
The patient has been taking prednisone 20 mg daily, which exceeds the allowed dose.
References:
Participants with a history of ILD, or those who are suspected of having symptomatic ILD, or those with pneumonitis.
There is no information on interstitial lung disease (ILD) or pneumonitis.
Individuals with a positive test for HIV, Hep B or Hep C are excluded unless it is well-controlled with no increased risk of immunosuppression and with no potential drug interactions with current antiviral therapy.
There is no information on HIV, Hep B, or Hep C status.
Participants with a history of other malignancies are excluded, except for those with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, or any cancer in situ that has been treated curatively, and the participant has been in complete remission for more than two years with any cancer prior to the start of the study.
There is no information on a history of other malignancies.
The patient meets several inclusion criteria such as age, gender, diagnosis, and ECOG performance status, and does not meet some exclusion criteria. However, there is insufficient information on key inclusion criteria such as sensitizing mutations, prior systemic therapy, measurable disease, and PD-L1 status, as well as exclusion criteria related to autoimmune diseases and other malignancies.
Provision of signed and dated informed consent form.
Provision of informed consent cannot be assessed from the available data.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Willingness to comply with study procedures cannot be assessed from the available data.
Male or female aged 18 years or older.
Patient is a 58-year-old female, meeting the age and gender criteria.
References:
Participants must have histologically or cytologically confirmed non-small cell lung cancer which is stage IV.
Patient has histologically confirmed stage IV non-small cell lung cancer.
References:
Participants should not have a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists in first line (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations).
No information on sensitizing mutations for FDA-approved targeted therapy is available.
Participants should not have received prior systemic anticancer therapy for advanced or metastatic disease. For patients who are recently diagnosed and received one cycle of chemotherapy while awaiting NGS/PDL-1 testing are allowed on study after discussion with medical monitor.
Patient is currently on chemotherapy regimen including Carboplatin, but prior systemic anticancer therapy for advanced disease is not confirmed.
Participants should have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Recent imaging shows stable disease, but measurable disease based on RECIST 1.1 is not confirmed.
Participants should have a life expectancy of at least 3 months.
Life expectancy of at least 3 months cannot be assessed from the available data.
Participants should have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
Patient has an ECOG performance status of 1, meeting the criterion.
References:
Participants should have provided tumor tissue from locations not radiated prior to biopsy; fresh formalin fixed specimens or archival samples which have been determined as PD-L1 status <1% or negative prior to randomization.
No information on tumor tissue PD-L1 status is available.
Participants should have been evaluated for circulating tumor DNA at baseline which has been determined to be detected, present or positive.
No information on circulating tumor DNA evaluation is available.
Participants with CNS metastases are eligible if all metastases have been treated and have remained stable without growth for at least 2 weeks post-treatment, the participant's neurological status has returned to baseline or remained stable for at least 2 weeks, and any use of corticosteroids for CNS metastases is at a dose of ≤10 mg daily prednisone (or an equivalent dose of another corticosteroid) and has been stable for at least 2 weeks before enrollment.
No information on CNS metastases treatment and stability is available.
Participants should have adequate organ function to be able to safely receive the approved standard of care regimens per the current FDA approved package insert, treating investigators discretion and institutional guidelines.
Adequate organ function to safely receive standard care regimens cannot be assessed from the available data.
For females of reproductive potential: Negative urine and serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, serum pregnancy test will be required. Participants should be willing to use an adequate method of contraception for the course of the study through 120 days after last dose of study medication or through 180 days after last dose of chemotherapeutic agents. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Negative pregnancy test and contraception use for females of reproductive potential cannot be assessed from the available data.
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Contraception use for males of reproductive potential is not applicable as the patient is female.
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks prior to administration of study regimen.
Patient is not currently participating in another study or receiving study therapy.
References:
Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
Patient has not received a live-virus vaccination in the past month.
References:
Has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis.
No information on clinically active diverticulitis, intra-abdominal abscess, GI obstruction, or abdominal carcinomatosis is available.
Prior treatment or history of allergy/hypersensitivity with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other specific T-cell co-stimulation or checkpoint targeting drugs.
No information on prior treatment or allergy/hypersensitivity with specific drugs is available.
Has a known sensitivity to any component of cisplatin, carboplatin, paclitaxel or pemetrexed.
Patient has no known allergies to medications, including cisplatin, carboplatin, paclitaxel, or pemetrexed.
References:
Participants with carcinomatous meningitis.
No information on carcinomatous meningitis is available.
Participants with active or suspected autoimmune diseases are excluded, with the following exceptions allowed: vitiligo, well-controlled type I diabetes mellitus, residual hypothyroidism due to autoimmune condition requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
No information on active or suspected autoimmune diseases is available.
Individuals who have received systemic corticosteroids or other immunosuppressive medications within the last 14 days prior to enrollment are excluded. Exceptions are made for topical, inhaled, nasal, ophthalmic steroids, or systemic corticosteroids at physiological doses not to exceed 10 mg/day of prednisone or an equivalent corticosteroid.
No information on systemic corticosteroids or immunosuppressive medications use is available.
Participants with a history of ILD, or those who are suspected of having symptomatic ILD, or those with pneumonitis.
No information on history of ILD, symptomatic ILD, or pneumonitis is available.
Individuals with a positive test for HIV, Hep B or Hep C are excluded unless it is well-controlled with no increased risk of immunosuppression and with no potential drug interactions with current antiviral therapy.
No information on HIV, Hep B, or Hep C status is available.
Participants with a history of other malignancies are excluded, except for those with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, or any cancer in situ that has been treated curatively, and the participant has been in complete remission for more than two years with any cancer prior to the start of the study.
No information on history of other malignancies is available.
The patient does not meet exclusion criteria due to active autoimmune condition (mild asthma) and use of systemic corticosteroids (prednisone).
Provision of signed and dated informed consent form.
Provision of informed consent is a future action and cannot be assessed at this time.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Willingness to comply with study procedures is a future action and cannot be assessed at this time.
Male or female aged 18 years or older.
Patient is a 48-year-old female, meeting the age and gender requirement.
References:
Participants must have histologically or cytologically confirmed non-small cell lung cancer which is stage IV.
Patient has a confirmed diagnosis of stage IV non-small cell lung cancer.
References:
Participants should not have a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists in first line (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations).
No information on known sensitizing mutations for which an FDA-approved targeted therapy exists.
Participants should not have received prior systemic anticancer therapy for advanced or metastatic disease. For patients who are recently diagnosed and received one cycle of chemotherapy while awaiting NGS/PDL-1 testing are allowed on study after discussion with medical monitor.
Patient has not received prior systemic anticancer therapy for advanced or metastatic disease.
References:
Participants should have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
No information on measurable disease based on RECIST 1.1.
Participants should have a life expectancy of at least 3 months.
No specific information on life expectancy, but no indications of less than 3 months.
Participants should have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
Patient maintains a good level of daily activity, consistent with an ECOG performance status of 0.
References:
Participants should have provided tumor tissue from locations not radiated prior to biopsy; fresh formalin fixed specimens or archival samples which have been determined as PD-L1 status <1% or negative prior to randomization.
No information on tumor tissue PD-L1 status.
Participants should have been evaluated for circulating tumor DNA at baseline which has been determined to be detected, present or positive.
No information on circulating tumor DNA evaluation.
Participants with CNS metastases are eligible if all metastases have been treated and have remained stable without growth for at least 2 weeks post-treatment, the participant's neurological status has returned to baseline or remained stable for at least 2 weeks, and any use of corticosteroids for CNS metastases is at a dose of ≤10 mg daily prednisone (or an equivalent dose of another corticosteroid) and has been stable for at least 2 weeks before enrollment.
No information on CNS metastases or treatment status.
Participants should have adequate organ function to be able to safely receive the approved standard of care regimens per the current FDA approved package insert, treating investigators discretion and institutional guidelines.
No specific information on organ function, but vital signs are normal.
For females of reproductive potential: Negative urine and serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, serum pregnancy test will be required. Participants should be willing to use an adequate method of contraception for the course of the study through 120 days after last dose of study medication or through 180 days after last dose of chemotherapeutic agents. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Patient is female, but no information on pregnancy test or contraception use.
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Not applicable as the patient is female.
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks prior to administration of study regimen.
No information on current or recent participation in other studies.
Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
Patient has not received any live-virus vaccinations in the past month.
References:
Has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis.
No information on diverticulitis, intra-abdominal abscess, GI obstruction, or abdominal carcinomatosis.
Prior treatment or history of allergy/hypersensitivity with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other specific T-cell co-stimulation or checkpoint targeting drugs.
No history of allergy/hypersensitivity with specific drugs mentioned.
References:
Has a known sensitivity to any component of cisplatin, carboplatin, paclitaxel or pemetrexed.
No known drug allergies, but no specific information on sensitivity to cisplatin, carboplatin, paclitaxel, or pemetrexed.
Participants with carcinomatous meningitis.
No information on carcinomatous meningitis.
Participants with active or suspected autoimmune diseases are excluded, with the following exceptions allowed: vitiligo, well-controlled type I diabetes mellitus, residual hypothyroidism due to autoimmune condition requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
Patient has mild asthma managed with low-dose prednisone, which may be considered an active autoimmune condition.
References:
Individuals who have received systemic corticosteroids or other immunosuppressive medications within the last 14 days prior to enrollment are excluded. Exceptions are made for topical, inhaled, nasal, ophthalmic steroids, or systemic corticosteroids at physiological doses not to exceed 10 mg/day of prednisone or an equivalent corticosteroid.
Patient is on a low-dose prednisone regimen for mild asthma, which may exceed the allowed dose.
References:
Participants with a history of ILD, or those who are suspected of having symptomatic ILD, or those with pneumonitis.
No information on ILD, symptomatic ILD, or pneumonitis.
Individuals with a positive test for HIV, Hep B or Hep C are excluded unless it is well-controlled with no increased risk of immunosuppression and with no potential drug interactions with current antiviral therapy.
No information on HIV, Hep B, or Hep C status.
Participants with a history of other malignancies are excluded, except for those with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, or any cancer in situ that has been treated curatively, and the participant has been in complete remission for more than two years with any cancer prior to the start of the study.
No history of other malignancies mentioned.
The patient meets key inclusion criteria such as age, gender, confirmed stage IV NSCLC, and adequate organ function. No exclusion criteria are met based on available data.
Provision of signed and dated informed consent form.
Provision of informed consent cannot be assessed from the available data.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Willingness to comply with study procedures cannot be assessed from the available data.
Male or female aged 18 years or older.
Patient is a 58-year-old male, meeting the age and gender criteria.
References:
Participants must have histologically or cytologically confirmed non-small cell lung cancer which is stage IV.
Patient has histologically confirmed stage IV non-small cell lung cancer.
References:
Participants should not have a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists in first line (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations).
No information on sensitizing mutations for NSCLC is available.
Participants should not have received prior systemic anticancer therapy for advanced or metastatic disease. For patients who are recently diagnosed and received one cycle of chemotherapy while awaiting NGS/PDL-1 testing are allowed on study after discussion with medical monitor.
Patient is currently on chemotherapy, but prior systemic anticancer therapy status is unclear.
Participants should have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Recent imaging shows stable disease, but measurable disease based on RECIST 1.1 is not confirmed.
Participants should have a life expectancy of at least 3 months.
Life expectancy of at least 3 months cannot be assessed from the available data.
Participants should have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
Performance status on ECOG is not provided.
Participants should have provided tumor tissue from locations not radiated prior to biopsy; fresh formalin fixed specimens or archival samples which have been determined as PD-L1 status <1% or negative prior to randomization.
No information on tumor tissue PD-L1 status is available.
Participants should have been evaluated for circulating tumor DNA at baseline which has been determined to be detected, present or positive.
No information on circulating tumor DNA evaluation is available.
Participants with CNS metastases are eligible if all metastases have been treated and have remained stable without growth for at least 2 weeks post-treatment, the participant's neurological status has returned to baseline or remained stable for at least 2 weeks, and any use of corticosteroids for CNS metastases is at a dose of ≤10 mg daily prednisone (or an equivalent dose of another corticosteroid) and has been stable for at least 2 weeks before enrollment.
Patient has stable disease with no new metastases, but CNS metastases status is not specified.
Participants should have adequate organ function to be able to safely receive the approved standard of care regimens per the current FDA approved package insert, treating investigators discretion and institutional guidelines.
Patient has normal liver and kidney function, suggesting adequate organ function.
References:
For females of reproductive potential: Negative urine and serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, serum pregnancy test will be required. Participants should be willing to use an adequate method of contraception for the course of the study through 120 days after last dose of study medication or through 180 days after last dose of chemotherapeutic agents. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Not applicable as the patient is male.
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Patient's use of contraception methods is not specified.
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks prior to administration of study regimen.
Patient is not currently participating in another study or receiving investigational therapy.
References:
Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
Patient has not received any live-virus vaccinations in the past month.
References:
Has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis.
No mention of diverticulitis, intra-abdominal abscess, GI obstruction, or abdominal carcinomatosis.
References:
Prior treatment or history of allergy/hypersensitivity with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other specific T-cell co-stimulation or checkpoint targeting drugs.
No history of allergy/hypersensitivity with checkpoint targeting drugs is reported.
References:
Has a known sensitivity to any component of cisplatin, carboplatin, paclitaxel or pemetrexed.
No known sensitivity to cisplatin, carboplatin, paclitaxel, or pemetrexed is reported.
References:
Participants with carcinomatous meningitis.
No mention of carcinomatous meningitis.
References:
Participants with active or suspected autoimmune diseases are excluded, with the following exceptions allowed: vitiligo, well-controlled type I diabetes mellitus, residual hypothyroidism due to autoimmune condition requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
No mention of active or suspected autoimmune diseases.
References:
Individuals who have received systemic corticosteroids or other immunosuppressive medications within the last 14 days prior to enrollment are excluded. Exceptions are made for topical, inhaled, nasal, ophthalmic steroids, or systemic corticosteroids at physiological doses not to exceed 10 mg/day of prednisone or an equivalent corticosteroid.
Patient is using inhaled bronchodilators, which are exceptions to the exclusion criteria.
References:
Participants with a history of ILD, or those who are suspected of having symptomatic ILD, or those with pneumonitis.
No mention of ILD, symptomatic ILD, or pneumonitis.
References:
Individuals with a positive test for HIV, Hep B or Hep C are excluded unless it is well-controlled with no increased risk of immunosuppression and with no potential drug interactions with current antiviral therapy.
No mention of HIV, Hep B, or Hep C status.
Participants with a history of other malignancies are excluded, except for those with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, or any cancer in situ that has been treated curatively, and the participant has been in complete remission for more than two years with any cancer prior to the start of the study.
No history of other malignancies is reported.
References: