A Phase III Randomized, Controlled, Open-label, Multicenter, Global Study of Capmatinib in Combination With Osimertinib Versus Platinum - Pemetrexed Based Doublet Chemotherapy in Patients With Locally Advanced or Metastatic NSCLC Harboring EGFR Activating Mutations Who Have Progressed on Prior 1st / 2nd Generation EGFR-TKI or Osimertinib Therapy and Whose Tumors Are T790M Mutation Negative and Harbor MET Amplification (GEOMETRY-E)

A phase III randomized, controlled, open-label, multicenter, global study of capmatinib in combination with osimertinib versus platinum-pemetrexed based doublet chemotherapy in patients with locally advanced or metastatic NSCLC harboring EGFR activating mutations who have progressed on prior 1st / 2nd generation EGFR-TKI or osimertinib therapy and whose tumors are T790M mutation negative and harbor MET amplification (GEOMETRY-E)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041210072

Enrollment

245

Registered

2021-09-16

Start date

2021-12-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

- Drug: capmatinib film-coated tablet for oral use Other Name: INC280 - Drug: osimertinib tablet for oral use Other Names:Tagrisso, Tagrix - Drug: pemetrexed concentrate for solution for intravenous u

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologically or cytologically confirmed diagnosis of NSCLC with EGFR mutations known to be associated with EGFR TKI sensitivity, T790M negative and MET gene amplification - Stage IIIB/IIIC NSCLC - Patients must have failed maximum one prior line of therapy (either to 1st/2nd generation EGFR TKIs or osimertinib) for advanced/metastatic disease (stage IIIB/IIIC and must be candidates for platinum (cisplatin or carboplatin) - pemetrexed doublet based chemotherapy - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 - Participants must have recovered from all toxicities related to prior systemic therapy to grade =< 1 Common Terminology Criteria Adverse Event 5.0 (CTCAE v 5.0) - At least one measurable lesion as defined by RECIST 1.1

Exclusion criteria

Exclusion criteria: - Prior treatment with any MET inhibitor or HGF-targeting therapy - 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 - Carcinomatous meningitis - Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years - Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis - Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome - Clinically significant, uncontrolled heart diseases

Design outcomes

Primary

Measure	Time frame
1. Run-in part: Incidence of dose limiting toxicities (DLTs) [ Time Frame: 3 weeks ] Incidence of Dose Limiting Toxicities (DLT) during the first 21 days (3 weeks) of treatment for each dose level associated with administration of capmatinib in combination with osimertinib 2. Randomized part: Progression free survival (PFS) [ Time Frame: 37 months ] Progression free survival (PFS) per Blinded Independent Review Committee (BIRC) according to Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1)	—

Measure

Time frame

1. Run-in part: Incidence of dose limiting toxicities (DLTs) [ Time Frame: 3 weeks ] Incidence of Dose Limiting Toxicities (DLT) during the first 21 days (3 weeks) of treatment for each dose level associated with administration of capmatinib in combination with osimertinib 2. Randomized part: Progression free survival (PFS) [ Time Frame: 37 months ] Progression free survival (PFS) per Blinded Independent Review Committee (BIRC) according to Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1)

—

Countries

Argentine Republic, Federal Republic of Germany, French Republic, Hong Kong, Japan, Kingdom of Spain, Kingdom of Thailand, Kingdom of the Netherlands, Malaysia, People's Republic of China, Portuguese Republic, Republic of Austria, Republic of Bulgaria, Republic of Chile, Republic of Colombia, Republic of Croatia, Republic of Hungary, Republic of India, Republic of Italy, Republic of Korea, Republic of Lithuania, Republic of Poland, Republic of Singapore, Republic of Slovenia, Romania, Russian Federation, Socialist Republic of Viet Nam, State of Israel, Taiwan, United Kingdom of Great Britain and Northern Irela, United States of America

Contacts

Public ContactKyosuke Yamauchi

Novartis Pharma. K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026