Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02664935 | National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 423 | — | — | May 1, 2015 | Sep 1, 2025 | May 21, 2025 | 25 | United Kingdom |
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...