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NCT04667234
Expanded Access of Sotorasib
trial testing AMG 510 in Non Small-cell Lung Cancer. No longer available.
Quick facts
| Lead sponsor | Amgen |
|---|---|
| Status | NO LONGER AVAILABLE |
| Study type | EXPANDED_ACCESS |
| Sites | 55 locations across Taiwan, Saudi Arabia, Israel, Argentina, United States, Brazil |
Drugs / interventions tested
- AMG 510 — full drug profile →
Conditions studied
- Non Small-cell Lung Cancer — all drugs for Non Small-cell Lung Cancer →
- Locally Advanced Unresectable NSCLC — all drugs for Locally Advanced Unresectable NSCLC →
- Locally Advanced Metastatic NSCLC — all drugs for Locally Advanced Metastatic NSCLC →
Sponsor
Amgen — full company profile →
Who can join
Adults 18 to 99, any sex, with Non Small-cell Lung Cancer or Locally Advanced Unresectable NSCLC. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of this study is to provide expanded access to and characterize the safety profile of Sotorasib in participants with previously treated locally advanced/unresectable/metastatic non small-cell lung cancer (NSCLC) with KRAS p.G12C mutation in a real-world setting.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
KRAS mutation: from undruggable to druggable in cancer.
Huang L, Guo Z, Wang F, Fu L. · · 2021 · cited 728× · PMID 34776511 · DOI 10.1038/s41392-021-00780-4 -
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 -
Sotorasib: First Approval.
Blair HA. · · 2021 · cited 161× · PMID 34357500 · DOI 10.1007/s40265-021-01574-2 -
The path to the clinic: a comprehensive review on direct KRAS<sup>G12C</sup> inhibitors.
Kwan AK, Piazza GA, Keeton AB, Leite CA. · · 2022 · cited 142× · PMID 35045886 · DOI 10.1186/s13046-021-02225-w -
Oncogenic KRAS blockade therapy: renewed enthusiasm and persistent challenges.
Tang D, Kroemer G, Kang R. · · 2021 · cited 65× · PMID 34607583 · DOI 10.1186/s12943-021-01422-7 -
Targeting Small GTPases and Their Prenylation in Diabetes Mellitus.
Gendaszewska-Darmach E, Garstka MA, Błażewska KM. · · 2021 · cited 34× · PMID 34236862 · DOI 10.1021/acs.jmedchem.1c00410 -
RAS degraders: The new frontier for RAS-driven cancers.
Escher TE, Satchell KJF. · · 2023 · cited 32× · PMID 36945775 · DOI 10.1016/j.ymthe.2023.03.017 -
Emerging Pharmacotherapeutic Strategies to Overcome Undruggable Proteins in Cancer.
Lu Y, Yang Y, Zhu G, Zeng H, et al · · 2023 · cited 24× · PMID 37496997 · DOI 10.7150/ijbs.83026
Verify or expand the search:
- PubMed search for NCT04667234
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AMG 510
Trials testing the same drug.
- NCT05180422 — A Phase I/II Study of AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C · Phase 1, PHASE2 · withdrawn
- NCT05118854 — A Phase II Study of Neoadjuvant Sotorasib in Combination With Cisplatin or Carboplatin and Pemetrexed for Surgically Res · Phase 2 · recruiting
- NCT05599828 — A Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants · Phase 1 · completed
- NCT04303780 — Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). · Phase 3 · active not recruiting
- NCT04380753 — AMG 510 Ethnic Sensitivity Study (CodeBreaK 105). · Phase 1 · completed
Other Amgen trials
Trials by the same sponsor.
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- NCT07493512 — Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer · Phase 1 · not yet recruiting
- NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
- NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
- NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · recruiting
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 NCT04667234 (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 Amgen
- Last refreshed: 13 August 2025
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/NCT04667234.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing