NCT05118854

A Phase II Study of Neoadjuvant Sotorasib in Combination With Cisplatin or Carboplatin and Pemetrexed for Surgically Resectable Stage IIA-IIIB Non-Squamous Non-Small Cell Lung Cancer With a KRAS p.G12C Mutation

Recruiting now Phase 2 Last updated 20 October 2025

What this trial tests

Phase 2 trial testing AMG 510 in Lung Cancer in 27 participants. Currently enrolling.

Timeline

30 March 2022

Primary endpoint
20 October 2027

20 October 2027

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	27
Start date	30 March 2022
Primary completion	20 October 2027
Estimated completion	20 October 2027
Sites	2 locations across United States

Drugs / interventions tested

• AMG 510 — full drug profile →
• Cisplatin (cisplatin) — full drug profile →
• Carboplatin (Carboplatin) — full drug profile →
• Pemetrexed — full drug profile →

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase II, single-arm, open-label study evaluating the efficacy, safety and tolerability of neoadjuvant sotorasib in combination with cisplatin (or carboplatin) and pemetrexed chemotherapy for patients with surgically resectable stage IIA - IIIB (T3-T4/N2) (based on AJCC 8th edition), non-squamous NSCLC with a KRAS p.G12C mutation. The primary objective of the study is to determine whether neoadjuvant therapy with 4 cycles of at least one dose of sotorasib plus cisplatin (or carboplatin) and pemetrexed can be administered safely and result in improved MPR rate in patients with KRAS p.G12C-mutant non-squamous NSCLC compared with the historical control MPR rate for platinum-based chemotherapy alone.

Publications & conference data

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

1. The current state of the art and future trends in RAS-targeted cancer therapies.
   Punekar SR, Velcheti V, Neel BG, Wong KK. · · 2022 · cited 382× · PMID 36028717 · DOI 10.1038/s41571-022-00671-9
2. 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
3. Can Cisplatin Therapy Be Improved? Pathways That Can Be Targeted.
   Ali R, Aouida M, Alhaj Sulaiman A, Madhusudan S, et al · · 2022 · cited 51× · PMID 35806243 · DOI 10.3390/ijms23137241
4. Targeting small GTPases: emerging grasps on previously untamable targets, pioneered by KRAS.
   Yin G, Huang J, Petela J, Jiang H, et al · · 2023 · cited 50× · PMID 37221195 · DOI 10.1038/s41392-023-01441-4
5. KRAS Mutations in Solid Tumors: Characteristics, Current Therapeutic Strategy, and Potential Treatment Exploration.
   Yang Y, Zhang H, Huang S, Chu Q. · · 2023 · cited 50× · PMID 36675641 · DOI 10.3390/jcm12020709
6. 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
7. 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
8. The Therapeutic Landscape for <i>KRAS</i>-Mutated Colorectal Cancers.
   Tria SM, Burge ME, Whitehall VLJ. · · 2023 · cited 33× · PMID 37190303 · DOI 10.3390/cancers15082375