IshanArya · December 18, 2025 23:43
diff --git a/oncology inclusion-exclusion b/oncology inclusion-exclusion
 INCLUSION CRITERIA:

 Age ≥18 years at the time of informed consent
 Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
 Stage IIIB/IV disease or recurrent disease not amenable to curative therapy
 Received at least one prior line of platinum-based chemotherapy with documented disease progression
 Measurable disease per RECIST v1.1 criteria (at least one lesion ≥10mm)
 Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
 Life expectancy ≥12 weeks
 Adequate organ function as defined by:

 Absolute neutrophil count ≥1,500/µL
 Platelet count ≥100,000/µL
 Hemoglobin ≥9.0 g/dL
 Total bilirubin ≤1.5× upper limit of normal (ULN)
 AST/ALT ≤2.5× ULN (or ≤5× ULN if liver metastases present)
 Creatinine clearance ≥50 mL/min (calculated or measured)


 Willing and able to provide written informed consent
 Willing to comply with study procedures and follow-up requirements

 EXCLUSION CRITERIA:

 Known activating EGFR mutations or ALK rearrangements (unless previously treated with appropriate targeted therapy)
 Untreated or symptomatic brain metastases (patients with treated, stable brain metastases off steroids for ≥2 weeks may be eligible)
 Prior treatment with investigational immunotherapy agent or checkpoint inhibitor
 Active autoimmune disease requiring systemic immunosuppression within the past 2 years
 History of organ transplantation requiring ongoing immunosuppression
 Known HIV, active hepatitis B or hepatitis C infection
 Active infection requiring systemic antimicrobial therapy
 Other active malignancy within the past 3 years (except adequately treated basal/squamous cell skin cancer, in situ cervical cancer, or localized prostate cancer)
 Systemic corticosteroid therapy (>10mg prednisone daily or equivalent) within 2 weeks prior to enrollment
 Major surgery within 4 weeks prior to study enrollment
 Pregnant or breastfeeding women (women of childbearing potential must have negative pregnancy test)
 Women of childbearing potential and men unwilling to use adequate contraception during study and for 6 months after last dose
 Known hypersensitivity to study drug or excipients
 Any condition that would interfere with ability to provide informed consent or comply with study requirements
	INCLUSION CRITERIA:

	Age ≥18 years at the time of informed consent
	Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
	Stage IIIB/IV disease or recurrent disease not amenable to curative therapy
	Received at least one prior line of platinum-based chemotherapy with documented disease progression
	Measurable disease per RECIST v1.1 criteria (at least one lesion ≥10mm)
	Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
	Life expectancy ≥12 weeks
	Adequate organ function as defined by:

	Absolute neutrophil count ≥1,500/µL
	Platelet count ≥100,000/µL
	Hemoglobin ≥9.0 g/dL
	Total bilirubin ≤1.5× upper limit of normal (ULN)
	AST/ALT ≤2.5× ULN (or ≤5× ULN if liver metastases present)
	Creatinine clearance ≥50 mL/min (calculated or measured)


	Willing and able to provide written informed consent
	Willing to comply with study procedures and follow-up requirements

	EXCLUSION CRITERIA:

	Known activating EGFR mutations or ALK rearrangements (unless previously treated with appropriate targeted therapy)
	Untreated or symptomatic brain metastases (patients with treated, stable brain metastases off steroids for ≥2 weeks may be eligible)
	Prior treatment with investigational immunotherapy agent or checkpoint inhibitor
	Active autoimmune disease requiring systemic immunosuppression within the past 2 years
	History of organ transplantation requiring ongoing immunosuppression
	Known HIV, active hepatitis B or hepatitis C infection
	Active infection requiring systemic antimicrobial therapy
	Other active malignancy within the past 3 years (except adequately treated basal/squamous cell skin cancer, in situ cervical cancer, or localized prostate cancer)
	Systemic corticosteroid therapy (>10mg prednisone daily or equivalent) within 2 weeks prior to enrollment
	Major surgery within 4 weeks prior to study enrollment
	Pregnant or breastfeeding women (women of childbearing potential must have negative pregnancy test)
	Women of childbearing potential and men unwilling to use adequate contraception during study and for 6 months after last dose
	Known hypersensitivity to study drug or excipients
	Any condition that would interfere with ability to provide informed consent or comply with study requirements
No results found