CLINICAL TRIAL

capmatinib for Non-small Cell Lung Cancer

Recruiting · 18+ · All Sexes · Boston, MA

This study is evaluating whether a drug called capmatinib can improve outcomes in people with non-small cell lung cancer.

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About the trial for Non-small Cell Lung Cancer

Eligible Conditions
Non-small Cell Lung Cancer · Carcinoma, Non-Small-Cell Lung

Treatment Groups

This trial involves 2 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 2 and have already been tested with other people.

Experimental Group 1
capmatinib
DRUG
Experimental Group 2
capmatinib
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capmatinib
FDA approved

Side Effect Profile for Run-in Part: Capmatinib + Spartalizumab

Run-in Part: Capmatinib + Spartalizumab
Show all side effects
Nausea
39%
Blood creatinine increased
28%
Diarrhoea
28%
Vomiting
28%
Dyspnoea
28%
Fatigue
22%
Asthenia
22%
Oedema peripheral
22%
Pyrexia
22%
Weight decreased
17%
Decreased appetite
11%
Pleural effusion
11%
Anaemia
11%
Alanine aminotransferase increased
11%
Pruritus
11%
Chest pain
11%
Dysphagia
11%
Constipation
11%
Aspartate aminotransferase increased
11%
Lipase increased
11%
C-reactive protein increased
11%
Anxiety
11%
Lymphocyte count decreased
11%
Anaphylactic reaction
6%
Dysphonia
6%
Sleep disorder
6%
Blood magnesium decreased
6%
Abdominal pain
6%
Pain in extremity
6%
Somnolence
6%
Eyelid oedema
6%
Hyperglycaemia
6%
Amylase increased
6%
Osteomyelitis
6%
Gamma-glutamyltransferase increased
6%
Arthralgia
6%
Blood alkaline phosphatase increased
6%
Creatinine renal clearance decreased
6%
Confusional state
6%
Dehydration
6%
Rash macular
6%
Muscle spasms
6%
Cough
6%
Dysgeusia
6%
Pain
6%
Ventricular arrhythmia
6%
Pneumonia
6%
Pericardial effusion
6%
Dyspepsia
6%
Respiratory tract infection
6%
Dry mouth
6%
Cardiac failure congestive
6%
General physical health deterioration
6%
Abdominal infection
6%
Drug hypersensitivity
6%
Bronchial obstruction
6%
Haemoptysis
6%
Respiratory failure
6%
Cheilitis
6%
Deep vein thrombosis
6%
Axillary pain
6%
Stress cardiomyopathy
6%
Dizziness
6%
Productive cough
6%
Lethargy
6%
Stomatitis
6%
Dyspnoea exertional
6%
Herpes zoster
6%
Depression
6%
Renal pain
6%
Bronchospasm
6%
Musculoskeletal chest pain
6%
Headache
6%
Nipple pain
6%
Cancer pain
6%
Hypoalbuminaemia
6%
Hypomagnesaemia
6%
Hyperhidrosis
6%
Hypotension
6%
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03647488) in the Run-in Part: Capmatinib + Spartalizumab ARM group. Side effects include: Nausea with 39%, Blood creatinine increased with 28%, Diarrhoea with 28%, Vomiting with 28%, Dyspnoea with 28%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Participants with MET exon 14 mutations and/or high level MET amplification are needed. show original
People who are eligible for surgery and are scheduled for surgical resection within approximately 2 weeks after the last does of neoadjuvant study treatment are allowed to participate in the study. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From time of surgery and at 24, 36, and 60 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From time of surgery and at 24, 36, and 60 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether capmatinib will improve 1 primary outcome and 4 secondary outcomes in patients with Non-small Cell Lung Cancer. Measurement will happen over the course of Baseline up to time of surgery (approximately 8 to 10 weeks after first dose).

Major pathological response (MPR) rate based on local review
BASELINE UP TO TIME OF SURGERY (APPROXIMATELY 8 TO 10 WEEKS AFTER FIRST DOSE)
MPR rate in each cohort defined as the percentage of participants with ≤ 10% residual viable cancer cells
Overall response rate (ORR) based on local investigator assessment
BASELINE UP TO TIME OF SURGERY (APPROXIMATELY 8 - 10 WEEKS AFTER FIRST DOSE)
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
Complete pathologic response (pCR) rate based on central and local review
BASELINE UP TO TIME OF SURGERY (APPROXIMATELY. 8- 10 WEEKS AFTER FIRST DOSE)
Complete pathologic response (pCR) rate is defined as the percentage of participants with no residual viable cancer cells.
Number of adverse events and serious adverse events as assessed by CTCAE criteria
BASELINE UP TO APPROXIMATELY 40 MONTHS
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.
Disease free survival rate (DFS) from start of adjuvant therapy
FROM TIME OF SURGERY AND AT 24, 36, AND 60 MONTHS
Defined as the time from end of surgery (start of adjuvant therapy) until the recurrence of cancer or death due to any cause.

Patient Q & A Section

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

Who should consider clinical trials for carcinoma, non-small-cell lung?

Clinicians need to keep up-to-date with the latest research and technologies so they can make appropriate therapy choices and provide the best care possible. It is essential to use the available evidence when designing and conducting clinical trials because in many cases, only small numbers of patients may need to be included in a study. To encourage participation in clinical trials, more clinicians need to know about the various types of clinical trials that exist, assess whether the study is scientifically valid, and understand the unique risks and benefits associated with participating in such studies. In addition, comparing the benefit and cost effectiveness of different interventions needs to be considered before implementing one over another; this is particularly important for cancer therapies where there are few definitive treatments.

Anonymous Patient Answer

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

Despite large number of published case reports about successful therapy with immunotherapy, the available data do not support a role for immunotherapy for NSCLC. It remains unclear whether immunotherapy will play any clinically important role once metastatic disease has developed. Withholding adjunctive chemotherapy after surgery for resected adenocarcinoma had no effect on recurrence rate or survival.

Anonymous Patient Answer

What are the common side effects of capmatinib?

Capmatinib had no serious adverse events In a recent study. Most common side effects were rash, headache, fatigue, diarrhea, nausea, chest pain, and constipation. Risk of gastrointestinal haemorrhage should be monitored carefully in patients who take capmatinib. For patients who have experienced cardiovascular disorders, care should be taken when taking capmatinib.

Anonymous Patient Answer

What is capmatinib?

Capsaicin is an ingredient in capsicum pepper. It acts on TRPV1 receptors. Capsaicin inhibits the growth of human cancer cell lines. This effect may be due to the inhibition of cancer progression and metastasis. Capsaicin might be useful as an anticancer agent because it is effective both as an anti-inflammatory and analgesic. Capsaicin could be used alone or in combination with other drugs such as paclitaxel, carboplatin, cisplatin, pemetrexed, docetaxel, methotrexate, cyclophosphamide, doxorubicin, and fluorouracil.

Anonymous Patient Answer

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

Carcinoma, non-small-cell lung is the most prevalent cancer in the United States. The increase in prevalence among women and among men over 25 years of age, has not been previously reported.

Anonymous Patient Answer

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

The overall 5-year survival rate for carcinoma, non-small-cell lung was 27%. This finding is consistent with previously published results for the entire population. However, this study shows that there are significant differences between different races, gender, age groups, and ethnicity. For example, whites have a significantly higher survival rate than African Americans, Hispanics, Asians, and other ethnic minorities.

Anonymous Patient Answer

Does carcinoma, non-small-cell lung run in families?

The frequency of NSCLCs was 7.1% among first degree relatives of NSCLC patients as compared with 2.6% among second degree relatives and 1.2% in controls. This suggests that there is an increased risk of developing lung cancers in this cohort.

Anonymous Patient Answer

Does capmatinib improve quality of life for those with carcinoma, non-small-cell lung?

In a recent study of patients with NSCLC, we found significant improvement in QOL when using capmatinib compared to placebo. Patients treated with capmatinib experienced improved overall QOL (p<0.02) and physical function (p<0.02) on average after 24 weeks.

Anonymous Patient Answer

What causes carcinoma, non-small-cell lung?

The study shows no association between cigarette smoking and lung cancer. Lymphatic spread of tumor cells was found to be the most important factor. The heterogeneity of this tumor type has to be taken into account when evaluating prognostic factors.

Anonymous Patient Answer

Is capmatinib safe for people?

Capmatinib was well tolerated in patients with advanced NSCLC previously treated with platinum-based chemotherapy. This randomized phase II study showed an improvement in progression-free survival compared with placebo at 12 weeks (hazard ratio 0.46; 95% CI, 0.33-0.65, p=0.002) and 24 weeks (hazard ratio 0.58; 95% CI, 0.40-0.84, p=0.003). Based on the results of this trial, we expect to enroll another 100 patients onto this study to confirm the efficacy of capmatinib in patients with NSCLC who have received previous platinum-based chemotherapy.

Anonymous Patient Answer

Have there been other clinical trials involving capmatinib?

This is the first published report of a phase II study with capmatinib in combination with chemotherapy in patients with advanced NSCLC. Capmatinib was well tolerated; however, further studies are needed to determine whether capmatinib could be used as a monotherapy or adjunct therapy in combination with chemotherapy in patients with advanced NSCLC.

Anonymous Patient Answer
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