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

NCT04507919 | Unknown

• 1 other identifier: CTMT212X2002I
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Small Cell Lung Carcinoma

Keywords

Non-small cell lung carcinoma (NSCLC); treatment of lung cancer after first metastasis; lung cancer, lung adenocarcinoma; Squamous cell lung carcinoma; Large-cell lung carcinoma; Non small cell lung carcinoma; Non small cell lung cancer; Non-small cell lung cancer; NSCLC; Large cell lung carcinoma; Large cell lung cancer; Compassionate Use; Cohort; Trametinib; Dabrafenib; TMT212

Interventions

Dabrafenib DRUG

150 mg

Also known as: twice daily (BID)

Trametininb DRUG

2.0 mg

Also known as: once daily (QD)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 3 (or equivalent) and is in stable clinical condition. NOTE: patient in rapidly deteriorating clinical condition prior to start of therapy should not be considered for this program.
• Does not require treatment with prohibited concomitant medications.
• Women of childbearing potential must have a serum beta-human chorionic gonadotropin (HCG) pregnancy test performed within 14 days prior to starting dabrafenib and trametinib treatment. Patients with a positive pregnancy test result are not eligible for the program. Patients with a negative pregnancy test result must agree to use an effective contraception method as described below throughout the treatment period and for a total of 16 weeks following the last dose of treatment.
• Contraceptive Methods for Females of Childbearing Potential:
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during dosing and for 16 weeks after stopping treatment with trametinib (for trametinib monotherapy trials); 2 weeks after stopping treatment with dabrafenib (for dabrafenib monotherapy trials); 16 weeks after stopping treatment with trametinib or 2 weeks after stopping treatment with dabrafenib whichever is longer (for trials of dabrafenib in combination with trametinib).
• Highly effective contraception methods include: (for dabrafenib monotherapy or combination therapy with trametinib)
• Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

You may not qualify if:

• Patients eligible for this Treatment Plan must not meet any of the following criteria:
• Female who is pregnant or nursing (patient must discontinue nursing in order to enroll in the program).
• NOTE: Safety and efficacy in pregnant or nursing women has not been investigated.
• 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.
• NOTE: Consideration may be given to those patients who have either (1) received prior BRAF therapy and there is disease progression in the CNS only or (2) discontinued prior BRAF therapy due to an adverse event that is not likely to recur in response to treatment with 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:
• LVEF\<LLN
• A QT interval corrected for heart rate using the Bazett's formula ≥ 480 msec;
• Clinically significant uncontrolled arrhythmias
• Acute coronary syndromes (including myocardial infarction and unstable angina).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Adenocarcinoma of Lung

Interventions

dabrafenib; BID protein, human

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 11, 2020
• Last Updated: November 12, 2024

Record last verified: 2024-11