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NCT05118854 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Lung Cancer, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
- 2
- Study locations
NCT05118854: Recruiting Phase 2 study of Lung Cancer, sponsored by M.D. Anderson Cancer Center.
NCT05118854 is a Phase 2 study of Lung Cancer that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 27 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05118854, a Phase 2 study of Lung Cancer, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG AMG 510
Study Locations (2)
New York
- Memorial Sloan Kettering Cancer Center - New York
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2022-03-30 |
| Est. Completion | 2027-10-20 |
| Phase | Phase 2 |
What NCT05118854 shows while recruiting
NCT05118854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT05118854 reports a single indexed study location in New York, Texas.
Frequently Asked Questions
What is clinical trial NCT05118854 about?
NCT05118854 is a clinical study titled "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". 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-s...
What is the current status of trial NCT05118854?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2022-03-30. Estimated completion is 2027-10-20.
What conditions does trial NCT05118854 study?
This clinical trial studies the following conditions: Lung Cancer.
What interventions are being tested in trial NCT05118854?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), AMG 510 (DRUG).
Who is sponsoring clinical trial NCT05118854?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05118854 being conducted?
This trial has 2 study locations across New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05118854's enrollment target sits among peer trials
27 334th of 409 higher than 76 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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