Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD4547 · 1 trial · 3 indications
CT scans every 6 weeks from baseline until disease progression (Primary outcome for all Trial Arms except Arm C). Investigators expect patients to participate in the study for a maximum of 18 months, however cannot guarantee that some patients may participate over 18 months.
Defined as the time from commencement of trial treatment to the date of CT scan when progressive disease first recorded or date of death without previously recorded progression (Primary Outcome for Arm C only). Patients who are alive with no recorded progression at the time of analysis will be censored at the date of the CT scan when they were last recorded with an evaluable measure that was not progression. Investigators expect patients to participate in the study for a maximum of 18 months, however, cannot guarantee that some patients may participate over 18 months.
A patient will be defined as experiencing DCB if they remain free of disease progression at their fourth CT or MRI scan since treatment start date, i.e. approximately 24 weeks, or at any scan after 24 weeks that shows the patient free of disease progression (co-primary outcome for all Trial Arms except Arm C \& G)
| Arm | Type | Description |
|---|---|---|
| Arm A: AZD4547 | EXPERIMENTAL | AZD4547 - FGFR Inhibitor Route \& Formulation: Oral, Tablets Strengths: 20 \& 80mg Trial Dose \& Schedule: 80 mg BD, Continuous dosing, 21 day cycle. |
| Arm B: Vistusertib (AZD2014) | EXPERIMENTAL | Vistusertib (AZD2014) - MTORC1/2 Inhibitor Route \& Formulation: Oral, Tablets Strengths: 25mg Trial Dose \& Schedule: 125 mg BD, Intermittent dosing (2 continuous days in 7), 28 day cycle. |
| Arm C: Palbociclib | EXPERIMENTAL | Palbociclib - CDK4/6 Inhibitor Route \& Formulation: Oral, Capsules Strengths: 75, 100 \& 125mg Trial Dose \& Schedule: 125 mg OD, Intermittent dosing (21 days on, 7 days off), 28 day cycle. |
| Arm D: Crizotinib | EXPERIMENTAL | Crizotinib - ALK Inhibitor Route \& Formulation: Oral, Capsules Strengths: 200 \& 250mg Trial Dose \& Schedule: 250 mg BD, Continuous dosing, 21 day cycle. |
| Arm E: Selumetinib & Docetaxel | EXPERIMENTAL | AZD6244 (Selumetinib) - MEK Inhibitor Route \& Formulation: Oral, Capsules Strengths: 25mg Trial Dose \& Schedule: 75 mg BD, Continuous dosing, 21 day cycle. Docetaxel - Chemotherapy Route \& Formulation: IV infusion over 30-60 minutes, concentrate for solution for infusion. Trial Dose \& Schedule: 75 mg/m2, 3-weekly, 21 day cycle. |
| Arm F: AZD5363 | EXPERIMENTAL | AZD5363 - AKT Inhibitor Route \& Formulation: Oral, Tablets Strengths: 80 \& 200mg Trial Dose \& Schedule: 480 mg BD, Intermittent dosing (4 days on, 3 days off), 28 day cycles. |
| Arm G: Osimertinib (AZD9291) | EXPERIMENTAL | Osimertinib (AZD9291) - EGFRM+ and T790M+ Inhibitor Route \& Formulation: Oral, Tablets Strengths: 80mg Trial Dose \& Schedule: 80 mg OD, Continuous dosing, 21 day cycles. |
| Arm NA: Durvalumab (MEDI4736) | EXPERIMENTAL | Durvalumab (MEDI4736) - Anti-PDL1 Route \& Formulation: IV Infusion, Lyophilized powder for solution for infusion Strengths: Vial containing 200mg Trial Dose \& Schedule: 10 mg/kg IV, 2-weekly. |
| Arm H: Sitravatinib | EXPERIMENTAL | Sitravatinib - VEGFR Inhibitor Route \& Formulation: Oral, Capsules Strengths: 10 \& 40mg Trial Dose \& Schedule: 120 mg OD, Continuous dosing, 21 day cycles. |
| Arm J: AZ6738 & Durvalumab | EXPERIMENTAL | AZD6738 - ATR Inhibitor Route \& Formulation: Oral, Tablets Strengths: 20mg, 80mg, 100mg Trial Dose \& Schedule: 240 mg twice daily (BD) on days 15-28 of 28 day cycle. Durvalumab (MEDI4736) - Anti-PDL1 Route \& Formulation: IV Infusion, Lyophilized powder for solution for infusion Strengths: Vial containing 500mg Trial Dose \& Schedule: 1500mg on day 1 of each 28 day cycle |
| Name | Type | Description |
|---|---|---|
| AZD4547 | DRUG | FGFR Inhibitor |
| Vistusertib | DRUG | MTORC1/2 Inhibitor |
| Palbociclib | DRUG | CDK4/6 Inhibitor |
| Crizotinib | DRUG | ALK/MET/ROS1 Inhibitor |
| Selumetinib | DRUG | MEK Inhibitor |
| Docetaxel | DRUG | Taxane, anti-mitotic cytotoxic chemotherapy |
| AZD5363 | DRUG | AKT Inhibitor |
| Osimertinib | DRUG | EGFRm+ T790M+ Inhibitor |
| Durvalumab | DRUG | Anti-PDL1 |
| Sitravatinib | DRUG | VEGFR Inhibitor |
| AZD6738 | DRUG | ATR inhibitor |
Core inclusion and exclusion criteria are presented below. Additional inclusion/exclusion criteria apply to each arm and are presented in the relevant arm supplements of the protocol. Inclusion Criteria: * Prior anti-cancer treatment: * Patients who refuse any standard of care first line therap...
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AZD4547 is an investigational small molecule being studied for the treatment of Non-Small Cell Lung Cancer (NSCLC), including squamous cell carcinoma and adenocarcinoma. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
AZD4547 is a targeted therapy that inhibits fibroblast growth factor receptors (FGFRs). It is being evaluated in biomarker-selected patients with Non-Small Cell Lung Cancer, meaning the trial enrolls individuals whose tumors harbor specific genetic alterations relevant to the drug's mechanism.
AZD4547 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 2 clinical trials for Non-Small Cell Lung Cancer.
AZD4547 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing trial is active but not recruiting participants, and the drug is being studied in patients with Non-Small Cell Lung Cancer.
AZD4547 is being evaluated in the National Lung Matrix Trial (NCT02664935), a multi-drug Phase II study in Non-Small Cell Lung Cancer. This trial is active but not recruiting, with a total enrollment of 423 participants across the United Kingdom. The study is controlled but not randomized or double-blinded.