AZD9291 in Combination With Ascending Doses of Novel Therapeutics
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Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
344actual
Sites
42
Countries
Canada, Japan, Poland +5
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2014-08-05 | actual | When the study began enrolling |
| Primary completion | 2020-03-04 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2014-05-21 | estimated | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced Non Small Cell Lung Cancer
Interventions
- Drug: Part A - AZD9291 in combination with AZD6094 — also filed as Osimertinib & Savolitinib/Volitinib
- Drug: Part A - AZD9291 in combination with continuous selumetinib (Asian subjects) — also filed as Osimertinib & ARRY-142886
- Drug: Part A - AZD9291 in combination with continuous selumetinib (non-Asian subjects) — also filed as Osimertinib & ARRY-142886
- Drug: Part A - AZD9291 in combination with intermittent selumetinib — also filed as Osimertinib & ARRY-142886
- Drug: Part A - AZD9291 in combination with MEDI4736 — also filed as Osimertinib & Durvalumab
- Drug: Part B - AZD9291 in combination with AZD6094 — also filed as Osimertinib & Savolitinib/Volitinib
- Drug: Part B - AZD9291 in combination with selumetinib — also filed as Osimertinib & ARRY-142886
- Drug: Part B - AZD9291 in combination with MEDI4736 — also filed as Osimertinib & Durvalumab
- Drug: Part C - AZD6094 monotherapy (Japan only) — also filed as Savolitinib/Volitinib
- Drug: Part C - AZD9291 in combination with AZD6094 (Japan only) — also filed as Osimertinib & Savolitinib/Volitinib
- Drug: Part D - AZD9291 in combination with AZD6094 — also filed as Osimertinib & Savolitinib/Volitinib
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of AZD9291 when given in combination with AZD6094 or selumetinib
measured Adverse events will be collected from baseline until 28 days after the last dose in the AZD6094 or selumetinib arms.
Number of participants with Adverse Events as a measure of Safety and Tolerability of AZD9291 when given in combination with AZD6094 or selumetinib
measured Adverse events: baseline until 28 days after the last dose in the AZD6094 or selumetinib arms.
Publications
- PMID 35181499 — linked by the registry
- PMID 33939068 — linked by the registry
- PMID 32139298 — linked by the registry
- PMID 32027846 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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