NO_LONGER_AVAILABLENot Applicable

Managed Access Program Cohort Treatment Plan CTMT212X2002I to Provide Access to Trametinib and Dabrafenib Combination Therapy for Patients With BRAF V600 Mutation-positive Advanced Non-Small Cell Lung Cancer

Plain-language summary

The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide guidance to the Physician for the treatment and monitoring of eligible patients diagnosed with BRAF V600E/K activating mutation-positive advanced NSCLC using trametinib/dabrafenib in the Cohort MAP CTMT212X2002I. The Physician should follow the suggested treatment guidelines. Furthermore, the Physician must comply with the MAP Agreement Letter and applicable local laws and regulations.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. Has or is willing to give consent to the Treating Physician in accordance with the local regulatory requirements, with age at the time of consent ≥18 years.
✓. Has the following diagnosis: Advanced (inoperable, metastatic or locally advanced, e.g. Stage IIIB, Stage IV) NSCLC (Non-Small Cell Lung Cancer) with confirmed BRAF V600E/K activating mutation.
✓. Patient is not eligible for any ongoing clinical trial in the same indication.
✓. Is receiving care at a clinical site with a Treating Physician who has experience with administering investigational agents for the end-stage NSCLC population, or the patient is willing and/or able to travel to a site and receive treatment under the guidance of physician with this experience. NOTE: The latter option would require the patient being evaluated in advance by the Treating Physician at the experienced site and his/her agreement to assume responsibility for the care of the patient.
✓. Is able to retain oral medication and swallow tablets/capsules (appropriate exceptions allowed for patients who are unable to swallow tablets/capsules - this is subject to availability of alternative (liquid) oral formulations).
✓. Does not require treatment with any (other) anti-cancer medication (exceptions might be allowed and are subject to individual evaluation).
✓. For patients with active brain metastases: the patient does not require or is ineligible for immediate local treatment.
✓. Is not eligible for participation in any ongoing clinical trials with dabrafenib and/or trametinib or has recently completed a clinical trial that has been terminated and, after considering other options (e.g., trial extensions, amendments, etc.), the clinical team has determined that treatment is necessary and there are no other feasible alternatives for the patient.

Exclusion criteria

✕. Female who is pregnant or nursing (patient must discontinue nursing in order to enroll in the program).
✕. Patients who have any lab abnormalities or AE/SAEs greater than Grade 3 (CTCAE v5.0).
✕. Concurrent treatment with other systemic anti-cancer therapies is not allowed, with the exception of whole brain radiation and brain radiosurgery. Patients who are currently being treated with another systemic anti-cancer therapy (e.g., chemotherapy, immune, biologic, or targeted therapy) must discontinue use prior to initiation of treatment with trametinib and dabrafenib. NOTE: Radiation skin injury has been reported with concurrent use of dabrafenib and radiation. All AEs/SAEs related to WBRT (whole brain radiation) or brain radiosurgery are required to resolve to Grade 1 or less (CTCAE 5.0) prior to start of the program treatment.
✕. Patients who have received prior therapy with a BRAF inhibitor other than dabrafenib.
✕. Presence of malignancy other than NSCLC within 1 year of enrolment into this program or any malignancy with confirmed activating RAS mutation. Patient with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is eligible. NOTE: Prospective RAS testing is not required. However, if the results of previous RAS testing are known, they must be used in assessing eligibility.
✕. Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib or dabrafenib, or excipients or to dimethyl sulfoxide (DMSO).
✕. Current evidence / risk of retinal vein occlusion (RVO) or central serous retinopathy.
✕. Current evidence of cardiovascular risk including any of the following:

Trial details

NCT IDNCT04507919

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

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