capmatinib for Carcinoma, Non-Small-Cell Lung

Phase-Based Estimates
2
Effectiveness
3
Safety
Novartis Investigative Site, Sunto Gun, Japan
capmatinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Non-Small-Cell Lung

Study Summary

This study is evaluating whether a drug combination can improve the survival of people with lung cancer.

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Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether capmatinib will improve 2 primary outcomes and 36 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of 3 weeks.

3 weeks
Run-in part: Incidence of dose limiting toxicities (DLTs)
37 months
Randomized part: Disease control rate (DCR)
Randomized part: Duration of intracranial response (DOIR)
Randomized part: Duration of response (DOR)
Randomized part: Intracranial Disease control rate (IDCR)
Randomized part: ORR for participants with MET amplification as measured in ctDNA
Randomized part: Overall Response Rate (ORR)
Randomized part: Overall Survival (OS)
Randomized part: PFS for participants with MET amplification as measured in circulating tumor DNA (ctDNA)
Randomized part: Progression free survival (PFS)
Randomized part: Progression-Free Survival after next line of treatment (PFS2)
Randomized part: Time to Response (TTR)
Randomized part: Time to intracranial response (TTIR)
Randomized part: Time to symptom deterioration for EORTC QLQ-C30 questionnaire
Randomized part: Time to symptom deterioration for EORTC QLQ-LC13 questionnaire
Randomized part: Time to symptom deterioration for EQ-5D-5L questionnaire
Randomized part: Time to symptom deterioration for NCCN FBrSl questionnaire
Randomized part: overall intracranial response rate (OIRR)
6 months
Run-in part only: Time to Response (TTR)
Run-in part: Disease control rate (DCR)
Run-in part: Dose intensity of each study drug
Run-in part: Duration of response (DOR)
Run-in part: Median Duration of exposure to each study drug
Run-in part: Overall Response Rate (ORR)
Run-in part: Percentage of participants with dose adjustments (reductions, interruptions or permanent discontinuation)
Run-in part: Progression-Free Survival (PFS)
Baseline, 37 months
Randomized part: change from baseline in the EORTC QLQ-C30 score
Randomized part: change from baseline in the EORTC QLQ-LC13 score
Randomized part: change from baseline in the EQ-5D-5L score
Randomized part: change from baseline in the NCCN FACT-Brain Symptom Index
Day 21
Randomized part: plasma concentration of capmatinib
Randomized part: plasma concentration of osimertinib and its metabolites
Day 21
Run-in part: Area Under the Curve (AUC) of capmatinib
Run-in part: Maximum plasma concentration (Cmax) of capmatinib
Run-in part: Time to maximum plasma concentration (Tmax) of capmatinib
Day 21
Run-in part: Area Under the Curve (AUC) of osimertinib and its metabolites
Run-in part: Maximum plasma concentration (Cmax) of osimertinib and its metabolites
Run-in part: Time to maximum plasma concentration (Tmax) of osimertinib and its metabolites

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

4 Treatment Groups

Platinum + pemetrexed based doublet chemotherapy (randomized part)
Combination of capmatinib + osimertinib (run-in part)

This trial requires 245 total participants across 4 different treatment groups

This trial involves 4 different treatments. Capmatinib is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Combination of capmatinib + osimertinib (run-in part)For run-in part: Up to 2 dose levels of capmatinib in combination with osimertinib may be investigated. The starting dose of combination is capmatinib 400 mg orally twice daily (b.i.d) and osimertinib 80 mg orally once per day (q.d). If a dose de-escalation is required, a lower dose level is defined as capmatinib 400 mg orally twice a day (b.i.d) and osimertinib 40 mg orally once per day (q.d.)
Combination of capmatinib + osimertinib (randomized part)For randomized part: capmatinib in combination with osimertinib administered at the recommended Phase III regimen (defined in the safety run-in part).
Platinum + pemetrexed based doublet chemotherapy (randomized part)For randomized part: following local guidelines as per standard of care and products labels Participants randomized to platinum-pemetrexed based doublet chemotherapy arm will be allowed to crossover to receive capmatinib in combination with osimertinib
platinum + pemetrexed based doublet chemotherapyFor randomized part: following local guidelines as per standard of care and products labels
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capmatinib
FDA approved
Osimertinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 37 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 37 months for reporting.

Closest Location

Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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) in order to receive the treatment. show original
At least one measurable lesion as defined by RECIST 1.1. show original
Key
You have a histologically or cytologically confirmed diagnosis of NSCLC with EGFR mutations known to be associated with EGFR TKI sensitivity, EGFR T790M negative and MET gene amplification. show original
You have stage IIIB/IIIC or IV NSCLC. show original
You have advanced/metastatic disease (stage IIIB/IIIC) and are candidates for platinum (cisplatin or carboplatin) - pemetrexed doublet based chemotherapy. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get carcinoma, non-small-cell lung a year in the United States?

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We estimated the rate of new cases of NSCLC annually at about 11 / 100,000 population. A large proportion of patients were diagnosed in the later stages.

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What are common treatments for carcinoma, non-small-cell lung?

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There is no cure for carcinoma, NOS. Current treatment is directed at symptom control, and is highly dependent on the type of treatment given. Common treatment options include anti-depressants and sedatives, and/or alpha-2 agonists in the presence of opioid treatment.

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Can carcinoma, non-small-cell lung be cured?

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Even when radical surgery is not possible, radiotherapy is the primary treatment of choice for lung cancer. Patients with carcinoma, non-small-cell lung, who have a 5-year survival rate greater than 90% seem to derive less benefit from adjuvant therapies.

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What causes carcinoma, non-small-cell lung?

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Smoking is the number one cause of cancer death in the United Kingdom. Other environmental hazards can also increase the risk, and the disease can develop spontaneously without genetic predisposition. Lung and other cancers can develop spontaneously from a mutation in the cells of the lung tissue. The main types of lung cancer to be tackled are lung adenocarcinoma and squamous-cell carcinoma, which are the predominant histopathological subtypes in this study.

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What is carcinoma, non-small-cell lung?

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The World Health Organization (2007) uses the epithet 'carcinoma,' but the terms 'cancer,''malignant cancer,''malignancy,''malignancy' and'malignant tumor' have a wider range of acceptable meanings, though not universally accepted. The World Health Assembly defines it as a life-threatening tumor that is initiated in the tissues and is not preceded by premalignant, preneoplastic or precancerous changes (WHO:1997).

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What are the signs of carcinoma, non-small-cell lung?

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Cancer of the lung is a heterogenous disease with several subcategories. Tumor heterogeneity can be explained by a number of different mechanisms including alterations of tumor suppressor genes, tumor suppressor signaling pathways, the epigenetic control of gene(s) that code for tumor suppressors, metabolic pathways, and tumor microenvironment.

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What is the average age someone gets carcinoma, non-small-cell lung?

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Average patient age for carcinoma is 58 +/- 5 years and for non-small-cell lung, the average patient age is 64 +/- 4 years at presentation. The percentage of patient with carcinoma has a decreasing trend for age and for stage of carcinoma. Male versus female patients and smokers versus nonsmokers have decreasing trends for age of carcinoma and for stage of carcinoma. The average age of the carcinoma patient was 58 +/- 5 years.

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What are the chances of developing carcinoma, non-small-cell lung?

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The incidence of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) after the first decade of life is much higher in the USA than in the UK. Rates per 100,000 in the USA were 7.1 for males, compared to 3.4 in the UK (1993–1994). Although smokers are more inclined to develop bronchioloalveolar cancer, more cases of carcinoma of the lung are attributed to environmental factors. The cumulative lifetime exposure to tobacco smoke is a major factor in the development of bronchioloalveolar cancer.

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What is the primary cause of carcinoma, non-small-cell lung?

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This article describes the predominant primary histology of lung squamous-cell carcinoma and adenocarcinoma and its subgroups with a summary of specific genitourinary cancers, as a comparison of these cancers with those typically associated with lung carcinomas. Lung-associated lung carcinomas are most commonly adenocarcinomas, which have a low or even nondetectable incidence of squamous cell carcinomas. They tend to develop more rapidly, to metastasize to distant sites, to express more EGFR and PDGFR tyrosine kinase receptors than squamous carcinomas, and more often than adenocarcinomas.

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Is capmatinib safe for people?

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There were no clinically relevant changes in capmatinib exposures when it was co-administered with food or liquids or with no food; therefore, safety of co-administered capmatinib was not altered by the presence and type of food.

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What are the common side effects of capmatinib?

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Common side effects occurred in more than half of the subjects treated with capmatinib and comprised headache, fatigue, nausea, rash/hand-foot, diarrhea, and muscle pain. Only 1 adverse event was observed in more than 10% of subjects in any grade for any assessment. The safety profile of capmatinib was acceptable based on the results of both this study and other phase I and phase II clinical trials.

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What is the survival rate for carcinoma, non-small-cell lung?

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Carcinoma (n = 10,827) is the most common form of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer), and mortality from lung cancer in 2010 was 1.6 times higher than from colon cancer (n = 9,767) in 2010. Overall survival for carcinoma (n = 10,827) was 62.9% at 5 yr, 68.7% at 10 yr, and 71.6% at 15 yr. Survival was similar for all other cancers combined (n = 8,446) (63.9%, 68.1%, and 73.0% at 5 yr, 10 yr, and 15 yr, respectively).

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