KRAS Clinical Trials

Through the KRAS Excellence Initiative (KRAS-X) at NYU Langone’s Perlmutter Cancer Center, people with KRAS-driven cancers and their providers can learn about current and upcoming clinical trials.

We’ve organized the following list by mutation type. For study details, click on the links below.

KRAS G12C

A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib Compared With Investigator’s Choice of Immunotherapy or Observation in Patients With Resected Stage II.III KRAS G12C-Positive Non-Small Cell Lung Cancer (Pending)

Investigator: Rajwanth Veluswamy, MD

NAUTIKA1: A Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-Selected Patients with Resectable Stages IB-III Non-Small Cell Lung Cancer

Investigator: Elaine Shum, MD

A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, And Pharmacokinetics of Divarasib

Investigator: Rajwanth Veluswamy, MD

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

Investigator: Joshua K. Sabari, MD

A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects with Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - the ONKORAS-101 Study

Investigator: Rajwanth Veluswamy, MD

A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Olomorasib Combination Therapy in Metastatic NSCLC KaRAnaSa (ISA-4)

Investigator: Joshua K. Sabari, MD

A Phase 1/2 Study of LY3537982 in Patients with KRAS G12C-Mutant Advanced Solid Tumors

Investigator: Joshua K. Sabari, MD

EAY191-E5: A Randomized Phase II Study of AMG 510 (Sotorasib) with or Without Panitumumab in Advanced Solid Tumors: A ComboMATCH Treatment Trial (Pending)

Investigator: Kristen Spencer, DO

KRAS G12D

A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, in Patients with Previously Treated, Advanced KRAS G12D-Mutated Non-Small Cell Lung Cancer (TARGET-D 202) (Pending)

Investigator: Rajwanth Veluswamy, MD

A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and with Cetuximab, in Patients with Metastatic KRAS G12D-Mutated Pancreatic Cancer (TARGET-D 201)

Investigator: Kristen Spencer, MD

A Study to Investigate Treatment with TCR-engineered T cells Recognizing KRAS Mutations Adult Subjects with Unresectable, Advanced, and/or Metastatic Solid Tumors (Pending)

Investigator: Salman R. Punekar, MD

MOONRAY-01: A Phase 1a/1b Trial of LY3962673 in Participants with KRAS G12D-Mutant Solid Tumors

Investigator: Paul E. Oberstein, MD

Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients with Solid Tumors with KRASG12D Mutation (Pending)

Investigator: Kristen Spencer, DO

A Phase 1/2a, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients with Advanced KRAS G12D-Mutant Solid Tumors

Investigator: Kristen Spencer, DO

Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG12D-Mutant Solid Tumors (Pending)

Investigator: Paul E. Oberstein, MD

A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination with mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants with KRAS G12D-mutated Metastatic Pancreatic Adenocarcinoma

Investigator: Paul E. Oberstein, MD

Incyte IN- A Randomized, Double Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (Pending)

Investigator: Manuel Hidalgo Medina, MD

KRAS G12V

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants with Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s) G12V (Pending)

Investigator: Rajwanth Veluswamy, MD

Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients with Advanced KRAS G12V-Mutant Solid Tumors (Pending)

Investigator: Salman R. Punekar, MD

Pan (Multi) RAS

RAS A Phase 1/2 Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with KRAS BRAF and Other Selected RAS/MAPK Mutation-Positive Malignancies

Investigator: Paul E. Oberstein, MD

Expanded Access Program to Treat Patients With Previously Treated Metastatic Pancreatice Adenocarcinoma with Daraxonrasib

Investigator: Paul E. Oberstein, MD

Open-label study of BBO-11818 in adult subjects with KRAS mutant cancer (Pending)

Investigator: Rajwanth Veluswamy, MD

A Phase 1/2 Multicenter Open-Label Study to Evaluate the Safety Tolerability and Preliminary Antitumor Activity of TNG462 in Combination with Other Agents in Patients with Pancreatic or Non-Small Cell Lung Cancer with MTAP Loss and RAS Mutation

Investigator: Kristen Spencer, DO

A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations (Pending)

Investigator: Salman R. Punekar, MD

RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of RMC-6236 versus Investigator’s Choice of Standard of Care Therapy in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) (Pending)

Investigator: Paul E. Oberstein, MD

Phase 3 Study of Daraxonrasib in Patients with Resected Pancreatic Ductal Adenocarcinoma (PDAC) (Pending)

Investigator: Paul E. Oberstein, MD

RAS-BRAF

A study to investigate the safety and efficacy of NST-628 oral tablets in subjects with solid tumors (Pending)

Investigator: Janice Mehnert, MD

Phase 1, FIH, open-label, nonrandomized, multicenter study of JZP815 in participants with advanced or metastatic solid tumors harboring alterations in the MAPK pathway (Pending)

Investigator: Rajwanth Veluswamy, MD