Study of safety and efficacy of capmatinib in combination with osimertinib compared to platinum - pemetrexed based doublet chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR activating mutations and T790M negative who have progressed on prior EGFR-TKI therapy

Phase 1

• Conditions: EGFR mutated, T790M negative NSCLC; MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003677-21-SI
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-14
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

1. Signed informed consent must be obtained prior to participation in the study.

2. Adult = 18 years old at the time of informed consent.

3. Stage IIIB/IIIC (not amenable to curative surgery or radiation) or IV NSCLC at the time of study entry.

4. Histologically or cytologically confirmed diagnosis of NSCLC with EGFR mutations known to be associated with EGFR TKI sensitivity, T790M negative, and MET gene amplification defined as Gene Copy Number (GCN) = 5 per central Novartis laboratory

5. Mandatory provision of a formalin-fixed, paraffin embedded tumor tissue sample (a newly obtained tumor sample, or archival tumor block/slides taken after progression on prior line of EGFR TKI.

6. Participants must have failed maximum one prior line of therapy (either to 1st/2nd generation EGFR TKIs or osimertinib) for advanced/metastatic disease and must be candidates for platinum (cisplatin or carboplatin) - pemetrexed doublet based chemotherapy.

7. At least one measurable lesion as defined by RECIST 1.1.

8. ECOG performance status (PS) of 0 or 1.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 98
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 147

Exclusion Criteria

1. Prior treatment with any MET inhibitor or HGF-targeting therapy.

2. Participants with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms

3. Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)

4. Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome

5. Treatment with a prior 1st or 2nd generation EGFR TKIs (e.g. erlotinib, gefitinib, afatinib, dacomitinib) or osimertinib within 14 days or approximately 5x half-life, whichever is shorter, of the first dose of study treatment

6. Unable or unwilling to swallow tablets as per dosing schedule

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified