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Non-Small Cell Lung CarcinomaPhase 4NCT05110196

Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC.

A Phase 4 study testing Capmatinib 150 mg and Capmatinib 200 mg in people with Non-Small Cell Lung Carcinoma, run by Novartis Pharmaceuticals at 15 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The Drugs Controller General of India (DCGI) granted approval for Rahika® (capmatinib) film-coated tablets (150 mg and 200 mg) for the treatment of adult patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbored a mutation leading to mesenchymal-epithelial transition (MET) exon 14… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Non-Small Cell Lung Carcinoma
What is being tested?
Capmatinib 150 mg and Capmatinib 200 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
15 sitesIndia
Study dates
3 Sep 2022to 4 Aug 2025
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent must be obtained prior to participation in the study.
  • Adult ≥18 years old at the time of informed consent.
  • Metastatic NSCLC (Stage IV, according to Version 8 of the AJCC Staging Manual) either treatment naïve or progressed (clinically and/or radiologically) on 1 or more lines of systemic therapy.
  • Histologically or cytologically confirmed diagnosis of NSCLC with confirmed EGFR wild type (EGFR Negative) and ALK rearrangement negative and who have tested positive MET exon14 skipping mutation (Locally available MET report either by reverse transcriptase polymerase chain reaction [RT-PCR] or NGS would be considered, in case not available, MET testing would be done through NGS based molecular pre-screening done as part of the study).
  • Patients must have recovered from all toxicities related to prior systemic therapies to grade ≤1 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).
  • At least one measurable lesion as defined by RECIST 1.1.
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  • Patients must have adequate organ function, including the following laboratory values at the screening visit:
  • Absolute neutrophil count ≥1.5 x 109/L without growth factor support
  • Platelets ≥100 x 109/L
  • Hemoglobin ≥9 g/dL
  • Calculated creatinine clearance (using Cockcroft-Gault formula) ≥45 mL/min
  • Total bilirubin ≤1.5 ULN (upper limit of normal) (except in patients with Gilbert's syndrome, who may be included if total bilirubin is ≤3.0 x ULN and direct bilirubin is ≤1.5 x ULN))
  • AST ≤3 x ULN, except for patients with liver metastasis, who may only be included if AST ≤5 x ULN
  • ALT ≤3 x ULN, except for patients with liver metastasis, who may only be included if ALT ≤5 x ULN
  • Alkaline phosphatase (ALP) ≤5.0 x ULN
  • Asymptomatic serum amylase ≤ grade 2. Patients with grade 1 or grade 2 serum amylase at the beginning of the study must be confirmed to have no signs and/or symptoms suggesting pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal imaging findings of pancreas, etc.)
  • Serum lipase ≤ ULN
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
  • Willing and able to comply with scheduled visits, treatment plan, and laboratory tests.

Who cannot join

  • Prior treatment with any MET inhibitor or hepatocyte growth factor targeting therapy.
  • Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers and completely resected carcinoma in situ of any type.
  • Patients 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.
  • Patients with 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.
  • 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).
  • Patient with clinically significant heart diseases like unstable angina/acute myocardial infraction within 6 months prior to screening, NYHA class III-IV congestive cardiac failure, uncontrolled hypertension, arrhythmias or QTcF ≥470 ms on the screening ECG.
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  • Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior (2 weeks for resection of brain metastases) to starting Capmatinib or who have not recovered from side effects of such procedure. Video-assisted thoracic surgery and mediastinoscopy will not be counted as major surgery and patients can be enrolled in the program ≥1 week after the procedure.
  • Thoracic radiotherapy to lung fields ≤4 weeks prior to starting Capmatinib or patients who have not recovered from radiotherapy-related toxicities. For all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs), radiotherapy ≤2 weeks prior to starting Capmatinib or patients who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions ≤2 weeks prior to starting Capmatinib is allowed.
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Capmatinib or patients who are unable to swallow oral tablets.
  • Patients receiving treatment with strong inducers of CYP3A that cannot be discontinued at least 1 week prior to the start of treatment with Capmatinib and for the duration of the study.
  • Unable or unwilling to swallow tablets as per dosing schedule.
  • Patients with known hypersensitivity to Capmatinib and any of the excipients of Capmatinib.
  • Patients with any other severe, acute or chronic medical or psychotic conditions or significant abnormal physical findings 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.
  • Patients with prior systemic anti-cancer (chemotherapy, immunotherapy, biologic therapy, vaccine) and investigational agents within 4 weeks or ≤5 x half-life of the agent (whichever is shorter) before the first dose of Capmatinib. If previous treatment is a monoclonal antibody, then the treatment must be discontinued at least 4 weeks before first dose of Capmatinib. If previous treatment is an oral targeted agent, then the treatment must be discontinued at least 5 times the half-life of the agent.
  • Pregnant or nursing (lactating) women.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 7 days after stopping study treatment. Highly effective contraception methods include:
  • Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
  • Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient.
  • Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking treatment.
  • Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 7 days after stopping study treatment. A condom is required for all sexually active male patients to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male patients must not donate sperm for the time period specified above.
  • Any other condition that would, in the Investigator's judgment, contraindicate patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., active infection (including active hepatitis B and C, SARS-CoV-2), inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

India15 sites

  • Novartis Investigative Site

    Bhopal, Madhya Pradesh, 462001

  • Novartis Investigative Site

    Bhubaneswar, Odisha, 751007

  • Novartis Investigative Site

    Gujarat, Gujarat, 380016

  • Novartis Investigative Site

    Hyderabad, Telangana, 500004

  • Novartis Investigative Site

    Kolkata, West Bengal, 700020

  • Novartis Investigative Site

    Mangalore, Karnataka, 575002

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400012

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400056

  • Novartis Investigative Site

    Nagpur, Maharashtra, 441108

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110029

  • Novartis Investigative Site

    Puducherry, 605006

  • Novartis Investigative Site

    Pune, Maharashtra, 411040

  • Novartis Investigative Site

    Thalassery, Kerala, 670103

  • Novartis Investigative Site

    Trivandrum, Kerala, 695011

  • Novartis Investigative Site

    Varanasi, Uttar Pradesh, 221005

Other trials in India

About this study

Official title: A Prospective, Multicenter, Open-label, Phase IV, Interventional Study to Assess the Safety and Efficacy of Capmatinib in Indian Patients With Mesenchymalepithelial Transition (MET) Exon 14 Skipping Mutation Positive Advanced Nonsmall Cell Lung Cancer (NSCLC).

The Drugs Controller General of India (DCGI) granted approval for Rahika® (capmatinib) film-coated tablets (150 mg and 200 mg) for the treatment of adult patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbored a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping. As a condition of approval, the DCGI required the conduct of a Phase IV clinical trial in Indian patients. As recommended by the DCGI, this Phase IV study was planned to evaluate the safety and efficacy of capmatinib in adult Indian patients with advanced or metastatic NSCLC with MET exon 14 skipping mutation-positive disease, in any line of therapy.

Read the detailed description

This was a Phase IV, prospective, multicenter, open-label, interventional study evaluating the safety and efficacy of capmatinib in Indian patients with metastatic non-small cell lung cancer (NSCLC) harboring a MET exon 14 skipping mutation, in any line of therapy. A total of 50 patients were included, with an overall study duration of approximately 2.5 years.

The study consisted of a molecular pre-screening phase of up to 28 days for patients without documented MET exon 14 skipping mutation-positive status, followed by a screening period of up to 28 days, a treatment period of 24 weeks (6 months), an end-of-treatment (EOT) visit, and a follow-up period of 30 days after the last dose of study treatment. Molecular testing was performed centrally using a next-generation sequencing (NGS)-based platform on formalin-fixed, paraffin-embedded (FFPE) tumor samples. Patients with confirmed MET exon 14 skipping mutation, epidermal growth factor receptor (EGFR) wild-type status, and anaplastic lymphoma kinase (ALK)-negative status were eligible for enrollment. Patients negative for MET exon 14 skipping mutation or positive for other biomarkers were excluded and treated according to standard of care.

All eligible participants received capmatinib as the investigational therapy. Capmatinib film-coated tablets (strengths of 150 mg and 200 mg) were administered orally at a starting dose of 400 mg twice daily (BID) on a continuous dosing schedule. Treatment was initiated only after prior anticancer therapy, if applicable, had been discontinued for at least 4 weeks or for a minimum of five times the drug half-life, whichever was longer. The treatment period began on Day 1 of Cycle 1, with each treatment cycle defined as 21 days. Cycle 2 began on Day 22 (Cycle 2 Day 22 [C2D22]), and subsequent cycles followed accordingly in the absence of temporary treatment discontinuation. Dose interruptions and dose reductions to 300 mg BID and subsequently 200 mg BID were permitted per protocol-defined criteria based on patient tolerability. Tablets were administered with or without food and were swallowed whole without chewing, crushing, or breaking.

Treatment was planned for a duration of 24 weeks and continued until disease progression, unacceptable toxicity, withdrawal of consent, or death, or at the discretion of the investigator or the patient. Efficacy assessments were performed every 6 weeks (±7 days) from Cycle 1 Day 1 until disease progression, with radiological assessments conducted using consistent imaging modalities throughout the study. Safety assessments included monitoring of adverse events, laboratory parameters, electrocardiograms (ECGs), and concomitant medications, and patients maintained subject diaries to assess treatment compliance.

Patients who discontinued treatment prematurely underwent end-of-study (EOS) assessments 30 days after administration of the last dose of study treatment. Patients who discontinued treatment without documented disease progression were followed for disease progression until EOS. Completion of the 30-day follow-up period marked EOS.

Post-trial access (PTA) to capmatinib was provided by Novartis to patients who were ongoing on treatment at the end of the planned study duration and were deriving clinical benefit, to ensure uninterrupted therapy beyond the study period. Patients transitioning to PTA were also required to complete the EOS visit assessments after the last dose of capmatinib administered within the study.

Being tested
Capmatinib 150 mg, Capmatinib 200 mg
Keywords
Carcinoma, Non-Small Cell Lung, Non-Small Cell Lung Cancer, Non small Cell Lung Cancer, Lung Neoplasms, Bronchial neoplasms, Mesenchymal-Epithelial Transition exon 14 Skipping Mutation Positive Advanced Non-Small Cell Lung Cancer, NSCLC, MET, Lung Cancer, Carcinoma
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Bronchial Neoplasms, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Capmatinib 150 mgDrug

    Also called Rahika® 150mg

    Capmatinib film-coated tablet 150 mg administered BID with or without food for 24 weeks. It should be swallowed whole and should not be broken, chewed, or crushed.

  • Capmatinib 200 mgDrug

    Also called Rahika® 200 mg

    Capmatinib film-coated tablet 200 mg administered BID with or without food for 24 weeks. It should be swallowed whole and should not be broken, chewed, or crushed.

Study groups in NCT05110196
Study groupRoleWhat they receive
CapmatinibExperimentalCapmatinib (Rahika®) film-coated tablet administered as 400 mg orally twice daily on a continuous dosing schedule for 24 weeks.
Receives: Drug: Capmatinib 150 mg; Drug: Capmatinib 200 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) and Serious Treatment-Emergent Adverse Events (Serious TEAEs)

    Treatment-emergent adverse events (TEAEs) were adverse events that occurred or worsened following initiation of study treatment and up to 30 days after the last dose of the study drug.

    Serious treatment-emergent adverse events (serious TEAEs) were TEAEs that met the criteria for a serious adverse event, defined as any adverse event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, or was an abnormal pregnancy outcome.

    Measured: From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 months

  2. Percentage of Participants With Dose Modifications

    Percentage of participants experiencing dose modifications, including dose interruptions and dose reductions. Dose modifications were implemented to manage intolerance to the protocol-specified regimen and were based on the worst preceding toxicity graded according to NCI-CTCAE v5.0. Capmatinib dose reductions followed predefined dose levels (400 mg BID → 300 mg BID → 200 mg BID), with a maximum of two consecutive reductions and no reductions below 200 mg BID. Treatment was discontinued if clinically significant toxicity recurred at the lowest dose despite maximal supportive measures, or if treatment interruption exceeded 21 consecutive days, unless continuation was approved by the Novartis Medical Lead or designee. Dose re-escalation was permitted once after at least one treatment cycle (3 weeks) at the reduced dose, provided no dose-modifying adverse event occurred.

    Measured: From first dose of study treatment administration until end of treatment, assessed up to approximately 6 months

  3. Dose Intensity

    Dose intensity was defined as the ratio of actual cumulative dose received to the actual duration of exposure.

    Measured: From first dose of study treatment administration until end of treatment, assessed up to approximately 6 months

Secondary outcomes (6)

  1. Overall Response Rate (ORR)

    Overall Response Rate (ORR) was defined as the proportion of subjects with a confirmed best overall response of complete response (CR) or partial response (PR), per RECIST v1.1 by investigator assessment.

    • Complete Response (CR) - Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) were required to have a reduction in short axis to < 10 mm (the sum could not be "0" if target nodes were present).
    • Partial Response (PR) - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From first dose of study treatment through study completion (up to approximately 34 months)

  2. Overall Intracranial Response Rate (OIRR)

    Overall Intracranial Response Rate (OIRR) was calculated as the overall response rate (ORR; complete response [CR] plus partial response [PR]) of lesions in the brain among patients with measurable intracranial disease at baseline, per RECIST v1.1 by investigator assessment.

    • Complete Response (CR) - Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) were required to have a reduction in short axis to < 10 mm (the sum could not be "0" if target nodes were present).
    • Partial Response (PR) - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From first dose of study treatment through study completion (up to approximately 34 months)

  3. Duration of Response (DOR)

    Duration of Response (DOR) was defined as the time from the first documented response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, as assessed by the investigator per RECIST version 1.1. Patients who did not experience disease progression or death from any cause were censored at the date of the last adequate tumor assessment prior to the start of any new antineoplastic therapy.

    It should be noted that the response counts presented in this section are based on confirmed best overall response (BOR) per RECIST v1.1 criteria. In contrast, response counts used in time-to-event analyses (e.g., DOR and time to response [TTR]) may differ, as these analyses are based on observed CR or PR at any assessment timepoint derived from raw data.

    Measured: From first documented response to disease progression or death, assessed through study completion (up to approximately 34 months)

  4. Time To Response (TTR)

    Time to Response (TTR) was defined as the time from the first dose of capmatinib to the first documented response of CR or PR, per RECIST v1.1 by investigator assessment.

    Measured: From first dose of study treatment through first documented response, assessed through study completion (up to approximately 34 months)

  5. Disease Control Rate (DCR)

    Disease Control Rate (DCR) was defined as the proportion of patients with CR or PR or stable disease (SD), per RECIST v1.1 by investigator assessment.

    • Complete Response (CR) - Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) were required to have a reduction in short axis to < 10 mm (the sum could not be "0" if target nodes were present).
    • Partial Response (PR) - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
    • Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of diameters recorded while on study.

    Measured: From first dose of study treatment through study completion (up to approximately 34 months)

  6. Progression Free Survival (PFS)

    Progression-Free Survival (PFS) was defined as the time from the first dose of capmatinib to the first documented disease progression per RECIST v1.1 by investigator assessment or death from any cause. If a patient had not progressed or was not known to have died at the date of the analysis cut-off or had received any further anticancer therapy, PFS was censored at the date of the last adequate tumor evaluation before the cut-off date or before the start of the new anticancer therapy, whichever occurred earlier. PFS was censored at the last adequate tumor assessment if one of the following occurred: (1) absence of an event, (2) the event occurred after initiation of a new anticancer therapy, or (3) the event occurred after two or more missing tumor assessments.

    Measured: From first dose of study treatment to first documented progression or death, assessed through study completion (up to approximately 34 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2021
  2. Study start3 Sep 2022
  3. Primary completion4 Aug 2025
  4. Study completion4 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05110196
Sponsor's protocol ID
CINC280AIN01
Status last verified
Sep 2026
First submitted
26 Oct 2021
Last updated
26 Oct 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Capmatinib 150 mg and Capmatinib 200 mg in people with Non-Small Cell Lung Carcinoma, run by Novartis Pharmaceuticals at 15 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) and Serious Treatment-Emergent Adverse Events (Serious TEAEs) (time frame: From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 7 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05110196.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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