Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC

Non-small Cell Lung Cancer Clinical Trial

— Geometry-N  

Official title:

Phase II Trial of Neoadjuvant and Adjuvant Capmatinib in Participants With Stages IB-IIIA, N2 and Selected IIIB (T3N2 or T4N2) NSCLC With MET Exon 14 Skipping Mutation or High MET Amplification (Geometry-N)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04926831
• Other study ID #: CINC280AUS12
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 10, 2022
• Est. completion date: August 6, 2026

Study information

• Verified date: December 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if neoadjuvant capmatinib can improve outcomes in participants with stages I-IIIA non-small cell lung cancer with MET exon 14 mutations and/or high MET amplification beyond those achieved with surgery, chemotherapy, and radiation.

Description:

This trial is a phase II, two cohort study of neoadjuvant capmatinib treatment (pre-surgery) which will be given for 8 weeks prior to a surgical resection and then followed by a three year adjuvant capmatinib treatment (post surgery). Following treatment, there will be a two year survival follow-up. The two molecularly defined cohorts will be enrolled in parallel. Approximately 38 evaluable participants will be enrolled in the study. During treatment participants will visit their treating physician to assess overall health status which will include lab-work and other safety assessments. Survival follow-up will be every 6 months which can be conducted via a telephone visit for up to approximately 2 years after end of treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4
• Est. completion date: August 6, 2026
• Est. primary completion date: August 6, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed NSCLC stage IB-IIIA, N2 and selected IIIB (T3N2 or T4N2)
• Participant must have either MET exon 14 mutations and/or high level MET amplification
• Participants must be eligible for surgery and scheduled for surgical resection within approximately 2 weeks after the last does of neoadjuvant study treatment.

Exclusion Criteria:

• Participants with unresectable or metastatic disease. All participants should have brain imaging (either MRI brain or CT brain with contrast) prior to enrollment to exclude brain metastasis.
• Prior treatment with any MET inhibitor or HGF-targeting therapy
• Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior to starting study treatment, or who have not recovered from side effects of such procedure.
• Prior systemic anti-cancer therapy (chemotherapy, immunotherapy, biologic therapy, vaccine) or investigational agents for NSCLC within the past 3 years.
• History of or current interstitial lung disease or pneumonitis Other protocol-defined inclusion/exclusion criteria may apply at the end

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• capmatinib
150 mg and 200 mg tablets for oral administration

Locations

Country	Name	City	State
United States	Fairfax-Northern Virginia Hematology-Oncology .	Fairfax	Virginia
United States	UCLA Oncology Hematology .	La Jolla	California
United States	University of California Davis Cancer Center .	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major pathological response (MPR) rate based on local review	MPR rate in each cohort defined as the percentage of participants with = 10% residual viable cancer cells	Baseline up to time of surgery (approximately 8 to 10 weeks after first dose)
Secondary	Complete pathologic response (pCR) rate based on central and local review	Complete pathologic response (pCR) rate is defined as the percentage of participants with no residual viable cancer cells.	Baseline up to time of surgery (approximately. 8- 10 weeks after first dose)
Secondary	Overall response rate (ORR) based on local investigator assessment	Overall response rate (ORR) is defined as the percentage participants with best overall response (BOR) of complete response (CR) or partial response ( PR) according to RECIST v1.1	Baseline up to time of surgery (approximately 8 - 10 weeks after first dose)
Secondary	Number of adverse events and serious adverse events as assessed by CTCAE criteria	The occurrence of adverse events will be reported from first day of treatment through end of treatment plus 30 days.; Serious adverse events which are treatment related will be reported through the end of study participation. Adverse events also may be detected or through physical examination findings, laboratory test findings, or other assessments.	Baseline up to approximately 40 months
Secondary	Disease free survival rate (DFS) from start of adjuvant therapy	Defined as the time from end of surgery (start of adjuvant therapy) until the recurrence of cancer or death due to any cause.	From time of surgery and at 24, 36, and 60 months