Comparing 4 approaches for advanced non-small cell lung cancer

Exclusion

• −Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.
• −Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).
• −Participants with known actionable genomic alteration (AGAs), including estimated glomerular filtration rate (EGFR), anaplastic lymphoma kinase (ALK), Repressor of Silencing 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), rearranged during transfection (RET), and mesenchymal-epithelial transition (MET), for which there are available first-line therapies per local standard-of-care (SOCStandard of careThe treatment normally given for a condition outside a study.Read more →) are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology.
• −Participants with clinically significant risk of hemorrhage or fistula are excluded.
• −Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
• −Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.
• −History of allogeneic organ / hematopoietic stem cell transplantation.
• −Participants with any of the following respiratory conditions:
• −Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis
• −Grade ≥3 pulmonary disease unrelated to underlying malignancy
• −History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial/severe venous thromboembolic events.
• −History of severe bleeding tendency or coagulation dysfunction
• −History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.
• −Participants with history of immunodeficiency
• −Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.
• −Previous systemic anti-tumor therapy including:
• −Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC.
• −Prior radiotherapy \> 30 Gy to the lung \< 6 months of first dose of study intervention
• −Palliative local therapy \< 2 weeks before the first dose of study intervention;
• −Non-specific immunomodulatory therapy \< 2 weeks before the first dose.
• −Prior systemic anti-angiogenic therapy
• −Prior and concomitant therapy:
• −therapeutic oral or parenteral anticoagulants or thrombolytic agents \< 10 days to the first dose.
• −chronic antiplatelet therapy \<7 days to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
• −live or attenuated live vaccine \< 4 weeks to the first dose.
• −current high-dose systemic corticosteroids.
• −prohibited concomitant medication(s) \< 21 days to the first dose.
• −Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.
• −Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and/or radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter \< 1 cm are permitted.
• −Major surgery \< 4 weeks or minor surgery \< 3 days prior to first dose of study intervention.
• −Previous treatment with immunotherapy
• −Prior immune-related AEAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → that led to anti-PD-(L)1 treatment discontinuation, adverse events from prior immunotherapy not improved to Grade 1 before screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, or required treatment with systemic immunosuppressive therapy.