Expanded Access to ABBV-400
Non-Small Cell Lung CancerThis is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-400 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.
Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1...
Non Small Cell Lung Cancer ALK Positive or ROS1 PositiveThis expanded access study has being designed following a demand from the FDA, given the increase in the number of request for single patient INDs for lorlatinib
Pre-Approval Access With Amivantamab (JNJ-61186372) in Participants With Metastatic Non-Small Cell...
Metastatic Non-Small Cell Lung CancerThe purpose of this expanded access program (EAP) is to provide amivantamab for the treatment of participants with metastatic non-small cell lung cancer who have epidermal growth factor receptor exon 20 insertion mutations, and whose disease has progressed during or after current standard of care platinum-based chemotherapy. This intermediate EAP may be considered for individuals with serious/life-threatening diseases or conditions, where there are no alternative treatments or where individuals have progressed following standard of care.
Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit...
Non Small Cell Lung Cancer (NSCLC)The purpose of this study is to provide gefitinib treatment to patients who, on completion or closure of other gefitinib clinical studies, were either receiving placebo treatment, or are continuing on the same dose and regimen of gefitinib established in their preceding study, for as long as the patients continue to derive benefit.
Managed Access Program Cohort Treatment Plan CTMT212X2002I to Provide Access to Trametinib and Dabrafenib...
Small Cell Lung CarcinomaThe 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.
Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced...
NRG1NRG1 Fusion12 moreMerus is providing single patient/named access to the HER2/HER3 bispecific antibody, MCLA-128, to patients with advanced NRG1-fusion positive solid tumor under this early access program who are ineligible for an ongoing MCLA-128 clinical trial or have other considerations that prevent access to MCLA-128 through an existing clinical trial. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual's medical history and program eligibility criteria.
Managed Access Programs for LDK378, Ceritinib
Anaplastic Lymphoma Kinase (ALK)- Positive TumorsNon-small Cell Lung Cancer (NSCLC)The purpose of this registration is to list Managed Access Programs (MAPs) related to LDK378, Ceritinib.
Rociletinib (CO-1686) USA Expanded Access Program
Non-small Cell Lung CancerTo provide access to rociletinib for patients with advanced or metastatic EGFR-mutant NSCLC who have been treated previously with EGFR directed therapy and have evidence of a T790M mutation (T790M+).
Treatment Plan CINC280A02001M to Provide Access to Capmatinib, for MET Exon 14 Skipping Non-Small...
CarcinomaNon-Small Cell Lung3 moreThe purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide guidance to the Physician for the treatment and monitoring of patients in the Cohort MAP. The Physician should follow the suggested treatment guidelines. Furthermore, the Physician must comply with the MAP Agreement Letter and applicable local laws and regulations.
Expanded Access for LOXO-260 in Participants With Cancer Caused by an Abnormal RET Gene That Did...
CarcinomaNon-Small-Cell Lung1 moreExpanded access for participants with cancer caused by an abnormal RET gene that did not respond/is no longer responding to treatment with a type of drug called a RET inhibitor. The treating physician/investigator contacts Loxo Oncology, Inc. when, based on their medical opinion, a patient meets the criteria for expanded access.