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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
Phase 1 trial testing Durvalumab in Lung Cancer. Withdrawn.
16 January 2024
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 25 April 2023 |
| Primary completion | 16 January 2024 |
| Estimated completion | 16 January 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Durvalumab — full drug profile →
- Adagrasib (ADAGRASIB) — full drug profile →
Conditions studied
- Lung Cancer — all drugs for Lung Cancer →
- Gastro-intestinal Cancer — all drugs for Gastro-intestinal Cancer →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT05848843
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05848843 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 23 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05848843.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing