Thoracic

Non-Small Cell Lung Cancer (NSCLC):

Stage I-III Trials:

CIRB #H-33418/ CTSU #A151216 (ALCHEMIST): Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

ALCHEMIST Sub-study:

CIRB #H-40717/ CTSU #A081801 (ACCIO): Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO (ACCIO)

WCG IRB #H-43210/ Merck #MK-7684A-006 (KEYVIBE-006): Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab with Pembrolizumab) in Combination with Concurrent Chemoradiotherapy followed by MK- 7684A Versus Concurrent Chemoradiotherapy followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III NSCLC

BMC IRB #H-43785/ LCMC LEADER: Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancers

WCG IRB #H-43834/ Genentech #ML41591 (NAUTIKA1): Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer

Metastatic Stage IV Trials:

WCG IRB #H-43631 / GSK #213824 (GALAXIES LUNG-201): A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants With Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non-Small-Cell Lung Cancer

CIRB #H-44518/ SWOG #S2302 (PRAGMATICA-LUNG): A Prospective Randomized Study of Ramucirumab Plus Pembrolizumab Versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

WCG IRB #H-44076/ Janssen #61186372NSC2002 (PALOMA-2): A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer

Advarra IRB #H-44434/ Eli Lilly #J3M-MC-JZQB (SUNRAY-01): A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression

Central IRB #H-44990/ SeaGen #SGNB6A-002: A randomized, phase 3, open-label study to evaluate SGN-B6A compared with docetaxel in adult subjects with previously treated non-small cell lung cancer (pending)

Small Cell Lung Cancer (SCLC):

CIRB #H-40325/ SWOG #S1827 (MAVERICK): MRI Brain Surveillance Alone versus MRI Surveillance and Prophylactic Cranial Irradiation: A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)

CIRB #H-41197/ NRG #LU007 (RAPTOR): RAndomized Phase II/III Trial Of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR trial

CIRB #H-42287/ NRG #CC009: Phase III Trial of Stereotactic Radiosurgery (SRS) versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for 10 or fewer Brain Metastases from Small Cell Lung Cancer (pending)

Esophageal/Stomach:

CIRB H-43647/ CTSU #A022102: Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab for First-Line Treatment of Metastatic HER2- Gastroesophageal Adenocarcinoma

Metastatic/Advanced 2nd+ Line Solid Tumors:

KRAS/NRAS/HRAS/BRAF positive
CIRB #H-42956/ ETCTN #10449: A Phase 1 Study of ZEN003694 in Combination with Binimetinib in Solid Tumors with RAS Pathway Alterations and Triple Negative Breast Cancer (temporary closure)