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NCT05848843

A Phase I Study of Adagrasib and Durvalumab for Treatment of Advanced Non-small Cell Lung Cancers and Gastro-intestinal Cancers Harboring KRAS G12C Mutations

Withdrawn Phase 1 Last updated 23 January 2024
What this trial tests

Phase 1 trial testing Durvalumab in Lung Cancer. Withdrawn.

Timeline
25 April 2023
Primary endpoint
16 January 2024
16 January 2024

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 1
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposetreatment
Start date25 April 2023
Primary completion16 January 2024
Estimated completion16 January 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

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

Who can join

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

Sponsor's own description

To find a recommended dose of the combination of adagrasib and durvalumab that can be given to patients with cancers that have a KRAS G12C mutation.

Publications & conference data

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

  1. 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
  2. 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
  3. Targeting KRAS mutations in pancreatic cancer: opportunities for future strategies.
    Linehan A, O'Reilly M, McDermott R, O'Kane GM. · · 2024 · cited 24× · PMID 38576709 · DOI 10.3389/fmed.2024.1369136
  4. Mechanistic Foundations of KRAS-Driven Tumor Ecosystems: Integrating Crosstalk among Immune, Metabolic, Microbial, and Stromal Microenvironment.
    Ma J, Fu S, Tan J, Han Y, et al · · 2025 · cited 5× · PMID 40485603 · DOI 10.1002/advs.202502714
  5. Adagrasib Treatment After Sotorasib-Related Hepatotoxicity in Patients With <i>KRAS</i><sup>G12C</sup>-Mutated Non-Small Cell Lung Cancer: A Case Series and Literature Review.
    Luo J, Florez N, Donnelly A, Lou Y, et al · · 2024 · cited 4× · PMID 38579193 · DOI 10.1200/po.23.00644
  6. Precision immune regulation in KRAS-mutated cancers: the final piece of the puzzle?
    Fu S, Ma J, Cai C, Tan J, et al · · 2025 · cited 3× · PMID 40611261 · DOI 10.1186/s13046-025-03444-1
  7. Targeting KRAS in colorectal cancer (Review).
    Zhang M, Wu D, Tang Y, Zhang L, et al · · 2025 · cited 1× · PMID 40692745 · DOI 10.3892/mco.2025.2873
  8. Adagrasib in the treatment of colorectal cancer.
    Haddad SF, Bouferraa Y, Nair KG. · · 2025 · cited 1× · PMID 40619745 · DOI 10.1080/14796694.2025.2524311

Verify or expand the search:

Other trials of Durvalumab

Trials testing the same drug.

Other recruiting trials for Lung Cancer

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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