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CarcinomaPhase 2NCT03240393

Study of Oral cMET Inhibitor INC280 in Chinese Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (NSCLC)

A Phase 2 study testing INC280 in people with Carcinoma and Non-Small-Cell Lung Cancer, run by Novartis Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult Chinese patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) who have received one or two prior lines of systemic therapy for advanced/metastatic disease as measured by overall response rate (ORR). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung Cancer
What is being tested?
INC280
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
31 Jul 2018to 26 Oct 2021
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stage IIIB or IV NSCLC (any histology) at the time of study entry
  • Histologically or cytologically confirmed diagnosis of NSCLC that is:
  • EGFR wt as per patient standard of care by a validated test
  • AND ALK-negative rearrangement as part of the patient standard of care by a validated test
  • AND (by central assessment) either:
  • Cohort 1: Pre-treated patients with cMET GCN ≥ 6 or
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  • Cohort 2: Pre-treated patients with cMET GCN ≥4 and < 6, or
  • Cohort 3: Pre-treated patients with cMET mutations regardless of cMET GCN, or
  • Patients must have failed one or two prior lines of systemic therapy for advanced/metastatic disease
  • At least one measurable lesion as defined by RECIST 1.1
  • Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter the study.
  • Patients must have adequate organ function
  • ECOG performance status (PS) of 0 or 1
  • Details and other protocol-defined inclusion criteria may apply

Who cannot join

  • Prior treatment with crizotinib, or any other cMET or HGF inhibitor
  • Patients with characterized EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 mutations
  • Patients with characterized ALK-positive rearrangement
  • Clinically significant, uncontrolled heart diseases.
  • Patients receiving treatment with medications that cannot be discontinued at least 1 week prior to first INC280 treatment and for the duration of the study:
  • Strong and moderate inhibitors of CYP3A4
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  • Strong inducers of CYP3A4
  • Impairment of GI function or GI disease that may significantly alter the absorption of INC280
  • Patients receiving treatment with any enzyme-inducing anticonvulsant
  • Previous anti-cancer and investigational agents within 4 weeks or ≤ 5 x half-life of the agent (whichever is longer) before first dose
  • Pregnant or nursing women
  • Women of child-bearing potential, unless they are using highly effective methods of contraception
  • Sexually active males unless they use a condom during intercourse
  • Other protocol-defined exclusion criteria may apply

About this study

Official title: Phase II Multicenter 3-cohort Study of Oral cMET Inhibitor INC280 in Chinese Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Received 1 or 2 Prior Lines of Systemic Therapy for Advanced/Metastatic Disease

A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult Chinese patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) who have received one or two prior lines of systemic therapy for advanced/metastatic disease as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.

Being tested
INC280
Keywords
Non Small Cell Lung Cancer, NSCLC, INC280, EGFR wild-type (wt), advanced non-small cell lung cancer, advanced/metastatic disease, Non-small cell lung carcinoma (NSCLC), treatment of lung cancer after first metastasis, lung cancer, lung adenocarcinoma, Non small cell lung carcinoma, Non-small cell lung cancer, MET exon 14 deletion, MET exon 14 skipping, MET exon 14 mutation, MET mutation, MET amplification, MET inhibitor, MET dysregulation, MET activation
Medical subject headings
Carcinoma, Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Lung Neoplasms, Adenocarcinoma of Lung

What participants receive

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

  • INC280Drug

    Also called capmatinib

    cMET GCN ≥ 6 cMET GCN ≥ 4 and < 6 cMET mutations

Study groups in NCT03240393
Study groupRoleWhat they receive
cMET GCN ≥ 6ExperimentalPre-treated patients with cMET GCN ≥ 6 treated with INC280 at 400mg BID
Receives: Drug: INC280
cMET GCN ≥ 4 and < 6ExperimentalPre-treated patients with cMET GCN ≥ 4 and < 6 treated with INC280 at 400 mgBID
Receives: Drug: INC280
cMET mutationsExperimentalPre-treated patients with cMET mutations regardless of cMET GCN treated with INC280 at 400mg BID
Receives: Drug: INC280

What is being measured

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

  1. ORR based on Central Radiology review/assessment (BIRC)

    Proportion of patients with a best overall response defined as complete response (CR) or partial response (PR) by Blinded Independent Review Committee (BIRC) assessment per RECIST 1.1

    Measured: at least 18 weeks

Secondary outcomes (16)

  1. Duration of Response (DOR) by BIRC - Key Secondary

    Calculated as the time from the date of the first documented CR or PR by Blinded Independent Review Committee (BIRC) per RECIST 1.1 to the first documented progression or death due to any cause for patients with PR or CR.

    Measured: at least 18 weeks

  2. ORR by Investigator

    ORR (complete response (CR)+ partial response (PR)) per RECIST 1.1 by investigator assessment

    Measured: at least 18 weeks

  3. Duration of Response (DOR) by investigator

    DOR per RECIST 1.1 by investigator assessment

    Measured: at least 18 weeks

  4. Time to Response (TTR) by BIRC

    TTR per RECIST 1.1 by BIRC assessment

    Measured: at least 18 weeks

  5. Time to Response (TTR) by investigator

    TTR per RECIST 1.1 by investigator assessment

    Measured: at least 18 weeks

  6. Disease Control Rate (DCR) by BIRC

    DCR per RECIST 1.1 by BIRC assessment

    Measured: at least 18 weeks

  7. Disease Control Rate (DCR) by investigator

    DCR per RECIST 1.1 by investigator assessment

    Measured: at least 18 weeks

  8. Progression-free Survival (PFS) by BIRC

    PFS per RECIST 1.1 by BIRC assessment

    Measured: at least 18 weeks

  9. Progression-free Survival (PFS) by investigator

    PFS per RECIST 1.1 by investigator assessment

    Measured: at least 18 weeks

  10. Overall Survival (OS)

    OS, defined as time from first dose of INC280 to death due to any cause

    Measured: at least 18 weeks

  11. Cmax profile of INC280

    Pharmacokinetics of INC280

    Measured: 6 weeks

  12. Cmax profile of INC280 metabolite CMN288

    Pharmacokinetics of INC280 metabolite CMN288

    Measured: 6 weeks

  13. Cmin profile of INC280

    Pharmacokinetics of INC280

    Measured: 6 weeks

  14. Cmin profile of INC280 metabolite CMN288

    Pharmacokinetics of INC280 metabolite CMN288

    Measured: 6 weeks

  15. Plasma concentration-time profiles of INC280

    Pharmacokinetics of INC280

    Measured: 6 weeks

  16. Plasma concentration-time profiles of INC280 metabolite CMN288

    Pharmacokinetics of INC280 metabolite CMN288

    Measured: 6 weeks

Timeline

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

  1. First posted7 Aug 2017
  2. Study start31 Jul 2018 (estimated)
  3. Primary completion26 Oct 2021 (estimated)
  4. Study completion26 Oct 2021 (estimated)

Why it stopped: Company Decision

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03240393
Sponsor's protocol ID
CINC280A2202
Status last verified
Jul 2018
First submitted
26 Jul 2017
Last updated
26 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Planned Shared Data Description: Copy and paste this 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 2 study testing INC280 in people with Carcinoma and Non-Small-Cell Lung Cancer, run by Novartis Pharmaceuticals.

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 14 inclusion and 14 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: withdrawn, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

ORR based on Central Radiology review/assessment (BIRC) (time frame: at least 18 weeks). 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 NCT03240393.

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 Jul 2018.

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