NCT05472623: Neo-Kan

Neoadjuvant KRAS G12C Directed Therapy With Adagrasib (MRTX849) With or Without Nivolumab

Withdrawn Phase 2 Last updated 15 September 2025

What this trial tests

Phase 2 trial testing Adagrasib in Resectable Non-Small Cell Lung Cancer. Withdrawn.

Timeline

21 March 2023

Primary endpoint
1 June 2025

1 September 2025

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Start date	21 March 2023
Primary completion	1 June 2025
Estimated completion	1 September 2025
Sites	1 location across United States

Drugs / interventions tested

• Adagrasib (ADAGRASIB) — full drug profile →
• Adagrasib/Nivolumab

Conditions studied

• Resectable Non-Small Cell Lung Cancer — all drugs for Resectable Non-Small Cell Lung Cancer →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

18 and older, any sex, with Resectable Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open label phase 2 clinical trial evaluating the clinical safety, feasibility and efficacy of neoadjuvant Adagrasib alone or in combination with nivolumab in patients with NSCLC with KRAS G12C mutation.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting the RAS/RAF/MAPK pathway for cancer therapy: from mechanism to clinical studies.
   Bahar ME, Kim HJ, Kim DR. · · 2023 · cited 519× · PMID 38105263 · DOI 10.1038/s41392-023-01705-z
2. Management of locally advanced non-small cell lung cancer: State of the art and future directions.
   Miao D, Zhao J, Han Y, Zhou J, et al · · 2024 · cited 99× · PMID 37985191 · DOI 10.1002/cac2.12505
3. Neoadjuvant Targeted Therapy in Resectable NSCLC: Current and Future Perspectives.
   Lee JM, McNamee CJ, Toloza E, Negrao MV, et al · · 2023 · cited 59× · PMID 37451404 · DOI 10.1016/j.jtho.2023.07.006
4. MYC and KRAS cooperation: from historical challenges to therapeutic opportunities in cancer.
   Casacuberta-Serra S, González-Larreategui Í, Capitán-Leo D, Soucek L. · · 2024 · cited 43× · PMID 39164274 · DOI 10.1038/s41392-024-01907-z
5. KRAS G12C inhibitor combination therapies: current evidence and challenge.
   Miyashita H, Kato S, Hong DS. · · 2024 · cited 39× · PMID 38756650 · DOI 10.3389/fonc.2024.1380584
6. Translating the evolving molecular landscape of tumors to biomarkers of response for cancer immunotherapy.
   Anagnostou V, Landon BV, Medina JE, Forde P, et al · · 2022 · cited 38× · PMID 36350985 · DOI 10.1126/scitranslmed.abo3958
7. Exploiting Tertiary Lymphoid Structures to Stimulate Antitumor Immunity and Improve Immunotherapy Efficacy.
   Petroni G, Pillozzi S, Antonuzzo L. · · 2024 · cited 35× · PMID 38381540 · DOI 10.1158/0008-5472.can-23-3325
8. Emerging precision neoadjuvant systemic therapy for patients with resectable non-small cell lung cancer: current status and perspectives.
   Godoy LA, Chen J, Ma W, Lally J, et al · · 2023 · cited 34× · PMID 36650586 · DOI 10.1186/s40364-022-00444-7