A Phase II, Multicenter, Two-cohort Study of Oral MET Inhibitor Capmatinib in Chinese Adult Patients With EGFR Wild-type (wt), ALK Rearrangement Negative, MET Exon 14 Skipping Mutations, Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Treatment Naive or Failed One or Two Prior Lines of Systemic Therapy

Plain English Summary

Study of Capmatinib in Chinese Adult Patients With Advanced Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation is a Phase 2 clinical trial sponsored by Novartis Pharmaceuticals studying Non-Small Cell Lung Cancer (NSCLC). This trial tests capmatinib, an oral targeted therapy, for advanced non-small cell lung cancer (NSCLC) in Chinese adults. It is for patients with a specific genetic mutation (MET exon 14 skipping) who have not received prior treatment or have failed one or two previous treatments. Participation involves taking capmatinib tablets twice daily and regular medical check-ups. Alternatives may include other targeted therapies, chemotherapy, or immunotherapy, depending on prior treatments and specific mutations. The trial aims to enroll 36 participants.

Official Summary

The purpose of the study was to learn whether the study treatment (capmatinib), which already shows efficacy and safety in non-Chinese patients, could help Chinese patients with controlling their lung cancer in a safe way. Participants had a type of lung cancer called non-small cell lung lancer (NSCLC), with a specific alteration in a part of their DNA (called mutation) of the MET gene, within a specific part of this gene called exon 14. Participants who had advanced (or metastatic) non-small cell lung cancer with specific mutations in the MET gene but without mutations in the EGFR or ALK genes, who were aged 18 years or older were enrolled in this study. The study drug, capmatinib (also known as INC280), is an oral drug that is called a 'targeted' medicine, which means it targets particular processes that may not be working properly in cancer cells (called dysregulation). The dysregulation of the MET signaling in cancer cells of patients with NSCLC is believed to make the cancer worse. Capmatinib has been shown to selectively block the effects of the MET gene and therefore may help in keeping the disease under control, stopping cancer cells from growing.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older of Chinese ethnicity with advanced NSCLC. Patients must have a confirmed MET exon 14 skipping mutation and be negative for EGFR and ALK mutations. Individuals who have not received any systemic therapy for advanced disease, or have failed one or two prior lines of therapy, are eligible. Patients must have at least one measurable tumor and adequate organ function, with an ECOG performance status of 0 or 1. This trial is studying Non-Small Cell Lung Cancer (NSCLC), so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how well capmatinib shrinks tumors, indicating its effectiveness in controlling the cancer. The specific primary outcome measures are: Overall Response Rate (ORR) Per RECIST v1.1 by BIRC Assessment (Up to approximately 125 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a specific genetic subtype of lung cancer (MET exon 14 skipping) in Chinese patients, aiming to provide a targeted treatment option where existing therapies may be less effective. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Non-Small Cell Lung Cancer (NSCLC), where improved treatment options are needed.

Investor Insight

This trial signals a focus on targeted therapies for specific genetic mutations in lung cancer within the Chinese market, a significant and growing oncology sector. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if your lung cancer has the MET exon 14 skipping mutation and if capmatinib is a suitable option for you. Understand the daily dosing schedule of capmatinib tablets and the frequency of clinic visits for monitoring. Be prepared for regular blood tests and imaging scans to assess treatment response and potential side effects. The trial is being conducted at 17 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 36 participants

Interventions

• DRUG: Capmatinib — 400 mg of capmatinib tablets, administered orally twice daily

Primary Outcomes

• Overall Response Rate (ORR) Per RECIST v1.1 by BIRC Assessment (Up to approximately 125 weeks)

Secondary Outcomes

• Duration Of Response (DOR) Per RECIST v1.1 by BIRC Assessment (Up to approximately 189 weeks (median 33.6 weeks))
• Overall Response Rate (ORR) Per RECIST v1.1 by Investigator Assessment (Up to approximately 189 weeks (median 33.6 weeks))
• Duration Of Response (DOR) Per RECIST v1.1 by Investigator Assessment (Up to approximately 189 weeks (median 33.6 weeks))
• Time To Response (TTR) Per RECIST v1.1 by BIRC and Investigator Assessment (Up to approximately 189 weeks (median 33.6 weeks))
• Disease Control Rate (DCR) Per RECIST v1.1 by BIRC and Investigator Assessment (Up to approximately 189 weeks (median 33.6 weeks))

Full Eligibility Criteria

Key Inclusion Criteria:

* Chinese adult ≥ 18 years old at the time of informed consent
* Histologically confirmed stage IIIB, IIIC or IV NSCLC at the time of study entry, not amenable to curative surgery or radiation or multi-modality therapy (according to staging definition in CSCO guidelines for primary lung cancer, 2019).
* Histologically or cytologically confirmed diagnosis of NSCLC that is:

  1. EGFR wt: The EGFR wt status assessed as part of standard of care (EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 L858R substitution mutations)
  2. AND ALK rearrangement negative: assessed as part of standard of care by validated test
  3. AND either:

Cohort 1: Treatment naive participants with MET mutations, or Cohort 2: Pre-treated participants with MET mutations

* Cohort 1: participants must not have received any systemic therapy for advanced/metastatic disease (stage IIIB, IIIC or IV NSCLC). Neo-adjuvant and adjuvant systemic therapies will not count as one prior line of treatment if relapse occurred \> 12 months from the end of the neo-adjuvant or adjuvant systemic therapy.
* Cohort 2: participants must have failed one or two prior lines of systemic therapy for advanced/metastatic disease (stage IIIB, IIIC or IV NSCLC).
* At least one measurable lesion according to RECIST v1.1.
* Adequate organ function
* ECOG performance status (PS) ≤1

Key Exclusion Criteria:

* Prior treatment with any MET inhibitor or HGF-targeting therapy.
* Known druggable molecular alterations (such as ROS1 translocation or BRAF mutation, etc.) which might be a candidate for alternative targeted therapies as applicable per local regulations and treatment guidelines.
* 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.
* Presence or history of interstitial lung disease or interstitial pneumonitis, including, clinically significant radiation pneumonitis affecting activities of daily living or requiring therapeutic intervention.
* Substance abuse, active infection (including active hepatitis B and C, participants whose disease is controlled under antiviral therapy are eligible, and human immunodeficiency virus (HIV) history positive) or other severe, acute, or chronic medical or psychotic conditions or laboratory abnormalities that in the opinion of the investigator may increase the risk associated with study participation, or that may interfere with the interpretation of study results.

Trial Locations

• Novartis Investigative Site, Xiamen, Fujian, China
• Novartis Investigative Site, Foshan, Guangdong, China
• Novartis Investigative Site, Guangzhou, Guangdong, China
• Novartis Investigative Site, Guangzhou, Guangdong, China
• Novartis Investigative Site, Guangzhou, Guangdong, China
• Novartis Investigative Site, Harbin, Heilongjiang, China
• Novartis Investigative Site, Zhengzhou, Henan, China
• Novartis Investigative Site, Wuhan, Hubei, China
• Novartis Investigative Site, Shenyang, Liaoning, China
• Novartis Investigative Site, Jinan, Shandong, China
• ...and 7 more locations

Frequently Asked Questions

Related Conditions

• Non-Small Cell Lung Cancer (NSCLC)
• MET Exon 14 Skipping Mutation
• EGFR Wild-Type NSCLC
• ALK Rearrangement Negative NSCLC
• Targeted Cancer Therapy
• Oncology
• Advanced Lung Cancer
• Metastatic Lung Cancer
• Genomic-Driven Therapy
• Precision Medicine

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