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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 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.

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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

Lung Cancer

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

FieldValue
Enrollment Target 27 participants
Start Date 2022-03-30
Est. Completion 2027-10-20
Phase Phase 2

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

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What the Registry Record Tells You About NCT05118854

The ClinicalTrials.gov registry entry for NCT05118854 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (97% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.