E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
cMET-dependent malignancies |
Malignant non-small cell lung cancer |
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E.1.1.1 | Medical condition in easily understood language |
cMET-dependent malignancies |
Malignant non-small cell lung cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048683 |
E.1.2 | Term | Advanced cancer |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate long term safety data (SAEs and AEs) |
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E.2.2 | Secondary objectives of the trial |
not applicable |
Not applicable |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Participant is currently receiving capmatinib treatment (within Novartis-sponsored study which is eligible and approved to transition patients to the rollover study) as single agent or in combination or is receiving a combination partner treatment alone. 2. Participant is currently deriving clinical benefit from the study treatment as determined by the Investigator. 3. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. 4. Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
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E.4 | Principal exclusion criteria |
1.Participant is currently not receiving any study treatment due to unresolved toxicities for which study drug dosing has been interrupted or permanently discontinued in the parent protocol (Patients meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow study treatment dosing to resume). 2.Pregnant or nursing (lactating) women. 3.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 at least 7 days or following combination treatment parent trial recommendation (which ever is longer) of study treatment after stopping medication. Sexually active males unwilling to use a condom during intercourse while taking study treatment and for at least 7 days or following combination treatment of the parent trial combination recommendation (whichever is longer) after stopping study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above. 4. Concurrent participation in another clinical study other than a parent clinical study 5. Participants who received live vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, TY21a typhoid vaccines and COVID-19 vaccines) within 30 days prior to the first dose of study treatment
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E.5 End points |
E.5.1 | Primary end point(s) |
Frequency and severity of AEs/SAEs |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Clinical and safety assessments every 12 weeks, including a 30 day safety follow-up visit after end of treatment |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
China |
Japan |
Korea, Republic of |
Singapore |
Taiwan |
United States |
France |
Germany |
Italy |
Belgium |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Study completion is defined as when the last participant finishes their last study visit and any repeat assessments associated with this visit have been documented and followed-up appropriately by the Investigator (e.g. each participant will be required to complete the study in its entirety and thereafter no further study treatment will be made available to them in the scope of the trial). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 26 |
E.8.9.2 | In all countries concerned by the trial years | 10 |