RecruitingPhase 2

Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy

Spain19 participantsStarted 2022-03-21

Plain-language summary

Open-label, non-randomised, exploratory, phase II, multi-centre clinical trial. 43 unresectable stage III (IIIA-N2, IIIB, IIIC) KRAS p.G12C non-small cell lung cancer patients will be enrolled in this trial to evaluate the efficacy of induction treatment of AMG510 (Sotorasib) plus AMG510 (Sotorasib) treatment post-induction as measured by Progression Free Survival at 12 months.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Tumor size ≥ 5 cm and lymph node N2 involvement
✓. The target lesion has to be bulky disease and/or more than 35% of the total volume of the two lungs should receive more than 20 Gy (V20) or inadequate pulmonary function
✓. Interstitial Lung diseases
✓. Prior treatment with thoracic radiotherapy for any reason
✓. Or under decision of a tumor committee as inappropriate due to local characteristics to perform treatment upfront

What they're measuring

Efficacy of the treatment in terms of the Progression Free Survival (PFS)

Timeframe: From the date of first dose of induction treatment until 6 months

Trial details

NCT IDNCT05398094

SponsorFundación GECP

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Eva Pereira

934302006 gecp@gecp.org

View on ClinicalTrials.gov More Non-small Cell Lung Cancer Stage III trials