Non-small Cell Lung CancerPhase 2NCT01610336
A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment
A Phase 2 study testing INC280 and Gefitinib in people with Non-small Cell Lung Cancer, run by Novartis Pharmaceuticals at 31 sites in 14 countries.
Trial summary
This study assessed the safety and efficacy of escalating doses INC280 when added to gefitinib in patients with lung cancer that were known to have dysregulation of the c-MET pathway and who had failed after benefiting on a prior treatment with either gefitinib or erlotinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- INC280 and Gefitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 31 sitesin 14 countries
- Study dates
- 5 Apr 2012to 27 May 2020
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented EGFR mutation
- Documented c-MET dysregulation
- Prior clinical benefit on EGFR inhibitors and then subsequent progression
- -≥ 18 year old
- Life expectancy of ≥ 3 months
- ECOG performance status ≤ 2
Who cannot join
- Unable to swallow tables once or twice daily
- Previous treatment with c-MET inhibitor
- Any unresolved toxicity from previous anticancer therapy greater than grade 1
- History of cystic fibrosis
- History of acute or chronic pancreatitis
- Unable to undergo MRI or CT scans
Show all 10Show fewer
- Known history of HIV
- Undergone a bone marrow or solid organ transplant
- Clinically significant wound or lung tumor lesions with increased likelihood of bleeding
- Pregnant or nursing
Trial locations and contacts
31 sites in 14 countries.
31 sites in 14 countries
South Korea5 sites
Novartis Investigative Site
Gyeonggi-do, Korea, 10408
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Seocho Gu, 06591
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 06351
China4 sites
Novartis Investigative Site
Beijing, 100039
Novartis Investigative Site
Guangzhou, Guangdong, 51000
Novartis Investigative Site
Guangzhou, 510060
Novartis Investigative Site
Shanghai, Shanghai Municipality, 200433
Australia3 sites
Novartis Investigative Site
Auckland
Novartis Investigative Site
East Bentleigh, Victoria, 3165
Novartis Investigative Site
Woolloongabba, Queensland, 4102
Italy3 sites
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Milan, MI, 20141
Novartis Investigative Site
Modena, MO, 41124
Netherlands3 sites
Novartis Investigative Site
Amsterdam, 1066 CX
Novartis Investigative Site
Maastricht, AZ, 5800
Novartis Investigative Site
Rotterdam, 3015 GD
France2 sites
Novartis Investigative Site
Strasbourg, 67091
Novartis Investigative Site
Toulouse, 31059
Germany2 sites
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Freiburg im Breisgau, 79106
Spain2 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Madrid, 28034
Taiwan2 sites
Novartis Investigative Site
Tainan, 70403
Novartis Investigative Site
Taipei, 10002
About this study
Official title: A Phase IB/II, Open Label, Multicenter Study of INC280 Administered Orally in Combination With Gefitinib in Adult Patients With EGFR Mutated, c-MET-amplified Non-small Cell Lung Cancer Who Have Progressed After EGFR Inhibitor Treatment
This study assessed the safety and efficacy of escalating doses INC280 when added to gefitinib in patients with lung cancer that were known to have dysregulation of the c-MET pathway and who had failed after benefiting on a prior treatment with either gefitinib or erlotinib.
Read the detailed description
The Phase Ib dose escalation part was aimed at the determination of the MTD/RP2D of capmatinib in combination with 250 mg gefitinib in patients with NSCLC patients with epidermal growth factor receptor (EGFR) mutation and cMET dysregulation and showing disease progression following EGFR tyrosine-kinase inhibitor (EGFR TKI) therapy. Dose escalation started with a dose of 100 mg/day to a maximum of 1200 mg/day, as capsule or tablet formulation. Successive cohorts of patients were to receive increasing doses of capmatinib in combination with a 250 mg once daily (qd) dose of gefitinib until the MTD/RP2D of capmatinib had been determined. The Phase II dose expansion part consisted of 400 mg capmatinib twice daily (bid), as either capsules or tablets, in combination with 250 mg gefitinib.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- INC280, Gefitinib
- Keywords
- EGFR, c-MET, Lung cancer, Gefitinib, Erlotinib, Non-small cell lung cancer (NSCLC), lung adenocarcinoma, large-cell lung carcinoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, 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
During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.
GefitinibDrug
Gefitinib 250 mg taken once daily
| Study group | Role | What they receive |
|---|---|---|
| INC280 100 mg Cap QD Phase Ib | Experimental | cap=capsule; QD=once daily Receives: Drug: INC280; Drug: Gefitinib |
| INC280 200 mg Cap QD Phase Ib | Experimental | cap=capsule; QD=once daily Receives: Drug: INC280; Drug: Gefitinib |
| INC280 400 mg Cap QD Phase Ib | Experimental | cap=capsule; QD=once daily Receives: Drug: INC280; Drug: Gefitinib |
| INC280 800 mg Cap QD Phase Ib | Experimental | cap=capsule; QD=once daily Receives: Drug: INC280; Drug: Gefitinib |
| INC280 200 mg Cap BID Phase Ib | Experimental | cap=capsule; BID=twice daily Receives: Drug: INC280; Drug: Gefitinib |
| INC280 400 mg Cap BID Phase Ib | Experimental | cap=capsule; BID=twice daily Receives: Drug: INC280; Drug: Gefitinib |
| INC280 600 mg Cap BID Phase Ib | Experimental | cap=capsule; BID=twice daily Receives: Drug: INC280; Drug: Gefitinib |
| INC280 200 mg Tab BID Phase Ib | Experimental | tab=tablet; BID=twice daily Receives: Drug: INC280; Drug: Gefitinib |
| INC280 400 mg Tab BID Phase Ib | Experimental | tab=tablet; BID=twice daily Receives: Drug: INC280; Drug: Gefitinib |
| INC280 400 mg Cap BID Phase II | Experimental | cap=capsule; BID=twice daily Receives: Drug: INC280; Drug: Gefitinib |
| INC280 400 mg Tab BID Phase II | Experimental | tab=tablet; BID=twice daily Receives: Drug: INC280; Drug: Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: Frequency of Dose Limiting Toxicities (DLTs)
A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.
Measured: Up to 215 weeks
Phase II : Overall Response Rate (ORR)
Overall response rate is defined as the proportion of patients with best overall response (BOR) of complete response (CR) or partial response (PR), as per RECIST 1.1 (Overall Response (OR) = CR + PR).
Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Measured: Until disease progression, up to 60.8 weeks
Secondary outcomes (12)
Phase Ib and II: Number of Participants With Adverse Events (AEs)
Adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: Up to 421 weeks
Phase Ib and II: Number of Participants With Serious Adverse Events (SAEs)
Serious adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: Up to 421 weeks
Phase Ib and II: Number of Patients With Dose Reductions of INC280 by Dose Level
Number of patients with dose reductions of INC280 by dose level as a measure of tolerability.
Measured: Up to 417 weeks
Phase Ib and II: Number of Patients With Dose Interruptions of Gefitinib by Dose Level
Number of patients with dose interruptions of gefitinib by dose level as a measure of tolerability
Measured: Up to 417 weeks
Phase II: Overall Survival (OS)
Overall survival is defined as the time from the start of treatment date to the date of death, due to any cause
Measured: From date of treatment until death due to any cause, up to 70.2 months
Phase II: Progression Free Survival (PFS)
Progression-free survivalis the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause.
Measured: Up to 60.8 months
Phase II: Duration of Response (DoR)
Duration of overall response (DOR) is defined as the time between the date of first documented response (CR or PR) and the date of first documented disease progression or death due to underlying cancer.
Measured: Up to 23.2 months
Phase I: PK Parameters AUCtau of INC280 and Gefitinib
PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis.
Area under the plasma concentration-time curve (AUC) from time zero to the end of dosing interval at steady state (tau), where tau=24 hours for once daily dosing and tau=12 hours for twice daily dosing
Measured: Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)
Phase I: PK Parameters Cmax of INC280 and Gefitinib
PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis.
Cmax is the maximum observed plasma concentration of INC280 and gefitinib
Measured: Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)
Phase I: PK Parameters Tmax of INC280 and Gefitinib
PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis.
Tmax is the time to reach maximum plasma concentration of INC280 and gefitinib
Measured: Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)
Phase I: PK Parameters Apparent Systemic Plasma Clearance Rate of INC280 and Gefitinib
PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis.
Apparent systemic plasma clearance rate of INC280 and gefitinib
Measured: Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)
Phase I: PK Parameters Half-life of INC280 and Gefitinib
PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis.
The elimination half-life of INC280 and gefitinib associated with the terminal slope (Lamda_z) of a semi-logarithmic plasma concentration-time curve
Measured: Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose)(Cycle=28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study start5 Apr 2012
- Primary completion10 Jun 2016
- Study completion27 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610336
- Sponsor's protocol ID
- CINC280X2202
- Other IDs
- 2011-002569-39
- Status last verified
- Mar 2021
- First submitted
- 3 Apr 2012
- Last updated
- 8 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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
Publications
Wu YL, Zhang L, Kim DW, Liu X, Lee DH, Yang JC, Ahn MJ, Vansteenkiste JF, Su WC, Felip E, Chia V, Glaser S, Pultar P, Zhao S, Peng B, Akimov M, Tan DSW. Phase Ib/II Study of Capmatinib (INC280) Plus Gefitinib After Failure of Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy in Patients With EGFR-Mutated, MET Factor-Dysregulated Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Nov 1;36(31):3101-3109. doi: 10.1200/JCO.2018.77.7326. Epub 2018 Aug 29.
PubMed 30156984
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB/II, Open Label, Multicenter Study of INC280 Administered Orally in Combination With Gefitinib in Adult Patients With EGFR Mutated, c-MET-amplified Non-small Cell Lung Cancer Who Have Progressed After EGFR Inhibitor Treatment
- ClinicalTrials.gov ID
- NCT01610336
- Acronym / sponsor ID
- CINC280X2202
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- EGFR, c-MET, Lung cancer, Gefitinib, Erlotinib, Non-small cell lung cancer (NSCLC), lung adenocarcinoma, large-cell lung carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2012 (actual)
- Primary completion
- 10 Jun 2016 (actual)
- Study completion
- 27 May 2020 (actual)
- First posted
- 4 Jun 2012 (estimated)
- Results
- Posted 8 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assessed the safety and efficacy of escalating doses INC280 when added to gefitinib in patients with lung cancer that were known to have dysregulation of the c-MET pathway and who had failed after benefiting on a prior treatment with either gefitinib or erlotinib.
Detailed description
The Phase Ib dose escalation part was aimed at the determination of the MTD/RP2D of capmatinib in combination with 250 mg gefitinib in patients with NSCLC patients with epidermal growth factor receptor (EGFR) mutation and cMET dysregulation and showing disease progression following EGFR tyrosine-kinase inhibitor (EGFR TKI) therapy. Dose escalation started with a dose of 100 mg/day to a maximum of 1200 mg/day, as capsule or tablet formulation. Successive cohorts of patients were to receive increasing doses of capmatinib in combination with a 250 mg once daily (qd) dose of gefitinib until the MTD/RP2D of capmatinib had been determined. The Phase II dose expansion part consisted of 400 mg capmatinib twice daily (bid), as either capsules or tablets, in combination with 250 mg gefitinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| INC280 100 mg Cap QD Phase Ib | Experimental | Drug: INC280, Drug: Gefitinibcap=capsule; QD=once daily |
| INC280 200 mg Cap QD Phase Ib | Experimental | Drug: INC280, Drug: Gefitinibcap=capsule; QD=once daily |
| INC280 400 mg Cap QD Phase Ib | Experimental | Drug: INC280, Drug: Gefitinibcap=capsule; QD=once daily |
| INC280 800 mg Cap QD Phase Ib | Experimental | Drug: INC280, Drug: Gefitinibcap=capsule; QD=once daily |
| INC280 200 mg Cap BID Phase Ib | Experimental | Drug: INC280, Drug: Gefitinibcap=capsule; BID=twice daily |
| INC280 400 mg Cap BID Phase Ib | Experimental | Drug: INC280, Drug: Gefitinibcap=capsule; BID=twice daily |
| INC280 600 mg Cap BID Phase Ib | Experimental | Drug: INC280, Drug: Gefitinibcap=capsule; BID=twice daily |
| INC280 200 mg Tab BID Phase Ib | Experimental | Drug: INC280, Drug: Gefitinibtab=tablet; BID=twice daily |
| INC280 400 mg Tab BID Phase Ib | Experimental | Drug: INC280, Drug: Gefitinibtab=tablet; BID=twice daily |
| INC280 400 mg Cap BID Phase II | Experimental | Drug: INC280, Drug: Gefitinibcap=capsule; BID=twice daily |
| INC280 400 mg Tab BID Phase II | Experimental | Drug: INC280, Drug: Gefitinibtab=tablet; BID=twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented EGFR mutation
- Documented c-MET dysregulation
- Prior clinical benefit on EGFR inhibitors and then subsequent progression
- -≥ 18 year old
- Life expectancy of ≥ 3 months
Key exclusion criteria (10 listed)
- Unable to swallow tables once or twice daily
- Previous treatment with c-MET inhibitor
- Any unresolved toxicity from previous anticancer therapy greater than grade 1
- History of cystic fibrosis
- History of acute or chronic pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INC280Also: CapmatinibDuring Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose. | Drug | INC280 100 mg Cap QD Phase Ib, INC280 200 mg Cap BID Phase Ib, INC280 200 mg Cap QD Phase Ib, INC280 200 mg Tab BID Phase Ib, INC280 400 mg Cap BID Phase II, INC280 400 mg Cap BID Phase Ib, INC280 400 mg Cap QD Phase Ib, INC280 400 mg Tab BID Phase II, INC280 400 mg Tab BID Phase Ib, INC280 600 mg Cap BID Phase Ib, INC280 800 mg Cap QD Phase Ib |
| GefitinibGefitinib 250 mg taken once daily | Drug | INC280 100 mg Cap QD Phase Ib, INC280 200 mg Cap BID Phase Ib, INC280 200 mg Cap QD Phase Ib, INC280 200 mg Tab BID Phase Ib, INC280 400 mg Cap BID Phase II, INC280 400 mg Cap BID Phase Ib, INC280 400 mg Cap QD Phase Ib, INC280 400 mg Tab BID Phase II, INC280 400 mg Tab BID Phase Ib, INC280 600 mg Cap BID Phase Ib, INC280 800 mg Cap QD Phase Ib |
Primary outcome
Phase Ib: Frequency of Dose Limiting Toxicities (DLTs)
Time frame: Up to 215 weeks
A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.
Phase II : Overall Response Rate (ORR)
Time frame: Until disease progression, up to 60.8 weeks
Overall response rate is defined as the proportion of patients with best overall response (BOR) of complete response (CR) or partial response (PR), as per RECIST 1.1 (Overall Response (OR) = CR + PR). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
12 secondary outcomes
Phase Ib and II: Number of Participants With Adverse Events (AEs)
Time frame: Up to 421 weeks
Phase Ib and II: Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 421 weeks
Phase Ib and II: Number of Patients With Dose Reductions of INC280 by Dose Level
Time frame: Up to 417 weeks
Phase Ib and II: Number of Patients With Dose Interruptions of Gefitinib by Dose Level
Time frame: Up to 417 weeks
Phase II: Overall Survival (OS)
Time frame: From date of treatment until death due to any cause, up to 70.2 months
Phase II: Progression Free Survival (PFS)
Time frame: Up to 60.8 months
Phase II: Duration of Response (DoR)
Time frame: Up to 23.2 months
Phase I: PK Parameters AUCtau of INC280 and Gefitinib
Time frame: Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)
Phase I: PK Parameters Cmax of INC280 and Gefitinib
Time frame: Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)
Phase I: PK Parameters Tmax of INC280 and Gefitinib
Time frame: Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)
Phase I: PK Parameters Apparent Systemic Plasma Clearance Rate of INC280 and Gefitinib
Time frame: Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)
Phase I: PK Parameters Half-life of INC280 and Gefitinib
Time frame: Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose)(Cycle=28 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30156984Wu YL, Zhang L, Kim DW, Liu X, Lee DH, Yang JC, Ahn MJ, Vansteenkiste JF, Su WC, Felip E, Chia V, Glaser S, Pultar P, Zhao S, Peng B, Akimov M, Tan DSW. Phase Ib/II Study of Capmatinib (INC280) Plus Gefitinib After Failure of Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy in Patients With EGFR-Mutated, MET Factor-Dysregulated Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Nov 1;36(31):3101-3109. doi: 10.1200/JCO.2018.77.7326. Epub 2018 Aug 29.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
31 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INC280 and Gefitinib in people with Non-small Cell Lung Cancer, run by Novartis Pharmaceuticals at 31 sites in 14 countries.
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 6 inclusion and 10 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in South Korea, China, Australia, Italy, Netherlands and 9 more countries. 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 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?
Yes. Results are posted in the registry (first posted 8 Apr 2021). 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?
Phase Ib: Frequency of Dose Limiting Toxicities (DLTs) (time frame: Up to 215 weeks). The study lists 2 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 NCT01610336, which also lists 1 linked publication.
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 8 Apr 2021.