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NCT04470674
Study of Durvalumab or Durvalumab Plus Chemotherapy in Kras Mutation Positive and PD-L1 High (≥ 50%) NSCLC Patients
Phase 2 trial testing Durvalumab in Lung Cancer. Withdrawn.
8 June 2021
Quick facts
| Lead sponsor | Shirish M Gadgeel |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 6 April 2021 |
| Primary completion | 8 June 2021 |
| Estimated completion | 8 June 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Durvalumab — full drug profile →
- Carboplatin (Carboplatin) — full drug profile →
- Pemetrexed — full drug profile →
Conditions studied
- Lung Cancer — all drugs for Lung Cancer →
- Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
- PD-L1 Gene Mutation — all drugs for PD-L1 Gene Mutation →
- KRAS Activating Mutation — all drugs for KRAS Activating Mutation →
Sponsor
Shirish M Gadgeel
Who can join
18 and older, any sex, with Lung Cancer or Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a two arm, randomized, phase II study of patients with advanced KRAS mutation positive and PD-L1 high NSCLC who have not received therapy for advanced stage disease. Patients will be randomized between Arm A and Arm B treatment. Arm A treatment will consist of durvalumab every 4 weeks for 13 cycles. Arm B treatment will consist of durvalumab with chemotherapy every 3 weeks for 4 cycles followed by durvalumab with pemetrexed every 3 weeks for 13 cycles.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Development of synthetic lethality in cancer: molecular and cellular classification.
Li S, Topatana W, Juengpanich S, Cao J, et al · · 2020 · cited 82× · PMID 33077733 · DOI 10.1038/s41392-020-00358-6 -
KRAS-Mutant Non-Small Cell Lung Cancer: An Emerging Promisingly Treatable Subgroup.
Xie M, Xu X, Fan Y. · · 2021 · cited 46× · PMID 34012925 · DOI 10.3389/fonc.2021.672612 -
Targeting KRAS in NSCLC: Old Failures and New Options for "Non-G12c" Patients.
Jacobs F, Cani M, Malapelle U, Novello S, et al · · 2021 · cited 14× · PMID 34944952 · DOI 10.3390/cancers13246332 -
[Application Progress of Immune Checkpoint Inhibitors
in Oncogene-driven Advanced Non-small Cell Lung Cancer].
Zhang T, Li B. · · 2021 · cited 1× · PMID 33819969 · DOI 10.3779/j.issn.1009-3419.2021.101.04
Verify or expand the search:
- PubMed search for NCT04470674
- 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 NCT04470674 (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 Shirish M Gadgeel
- Last refreshed: 3 March 2022
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/NCT04470674.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing