Summary
Olaparib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Lung Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Lung Cancer. ClinicalTrials.gov lists 8 registered trials linking Olaparib to Lung Cancer: 3 are currently recruiting; 2 are active or not yet recruiting; 2 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT03155620). It plans or enrolled 1377 participants. Registration activity spans 2016 to 2024. The literature layer holds 11 publications for this pair: 1 Cochrane review, 1 systematic review, 4 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2020 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Lung Cancer ranks 465 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous regression is rare (<0.5% of cases); 5-year survival without treatment: <5% for advanced NSCLC; ~20% for stage I-II with surgery.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 75.0 (trials 25.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 3 recruiting, 2 active / not yet recruiting, 2 completed, 1 other |
| Linked publications | 11 (5 clinical trial publications, 4 randomised controlled trial publications, 1 Cochrane review, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | BRCA1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT03155620 | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) 2017 | active, not recruiting | Phase 2 | 1,377 |
| NCT04939662 | Olaparib and Bevacizumab in Relapsed Small Cell Lung Cancer Subjects 2021 | completed | Phase 2 | 25 |
| NCT06419179 | Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in HRD Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC) 2024 | enrolling by invitation | Phase 2 | 29 |
| NCT05623319 | Pembrolizumab and Olaparib Treatment of Extensive Small Cell Lung Cancer (ES-SCLC) 2023 | recruiting | Phase 2 | 60 |
| NCT02734004 | A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors. 2016 | active, not recruiting | PHASE1, PHASE2 | 264 |
| NCT02769962 | Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer 2016 | completed | PHASE1, PHASE2 | 45 |
| NCT06217757 | Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC 2024 | recruiting | PHASE1, PHASE2 | 45 |
| NCT05975944 | Study of Selinexor Combined With Olaparib in Relapsed/Refractory Extensive Stage Small Cell Lung Cancer 2023 | status unknown | PHASE1, PHASE2 | 49 |
Published literature
- Clinical trial publication Olaparib in Patients With Solid Tumors With ATM Alterations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) StudyCarrizosa DR, Rothe M, Mangat PK et al. · JCO precision oncology · 2026 · PMID 41538762
- Clinical trial publication Olaparib in Patients With Solid Tumors With BRCA1/2 Alterations: Results From The Targeted Agent and Profiling Utilization Registry (TAPUR) StudyAl Baghdadi T, Rothe M, Mangat PK et al. · JCO precision oncology · 2025 · PMID 41100773
- Clinical trial publication Phase I Dose-Escalation Trial Combining Olaparib and Thoracic Radiotherapy in Extensive-Stage Small Cell Lung CancerRimner A, Lok BH, Gelblum DY et al. · Clinical cancer research : an official journal of the American Association for Cancer Research · 2025 · PMID 40880183
- Clinical trial publication The Phase 3 KEYLYNK-006 Study of Pembrolizumab Plus Olaparib Versus Pembrolizumab Plus Pemetrexed as Maintenance Therapy for Metastatic Nonsquamous NSCLCGray JE, Schenker M, Şendur MAN et al. · Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2025 · PMID 39521434
- Systematic review Olaparib monotherapy or combination therapy in lung cancer: an updated systematic review and meta- analysisHajihosseini S, Emami E, Zakavi SA et al. · Frontiers in oncology · 2025 · PMID 40224185
- Clinical trial publication Adavosertib in Combination with Olaparib in Patients with Refractory Solid Tumors: An Open-Label, Dose-Finding, and Dose-Expansion Phase Ib TrialHamilton EP, Falchook GS, Wang JS et al. · Targeted oncology · 2024 · PMID 39487373
- Cochrane review First-line treatment for advanced or metastatic EGFR mutation-positive non-squamous non-small cell lung cancer: a network meta-analysisZhang M, Sun L · Frontiers in oncology · 2024 · PMID 39882445
- Randomized controlled trial Olaparib maintenance versus placebo in platinum-sensitive non-small cell lung cancer: the Phase 2 randomized PIPSeN trialPostel-Vinay S, Coves J, Texier M et al. · British journal of cancer · 2024 · PMID 38097741
- Randomized controlled trial Olaparib as maintenance treatment in patients with chemosensitive small cell lung cancer (STOMP): A randomised, double-blind, placebo-controlled phase II trialWoll P, Gaunt P, Danson S et al. · Lung cancer (Amsterdam, Netherlands) · 2022 · PMID 35872530
- Randomized controlled trial Comprehensive Genome Profiling in Patients With Metastatic Non-Small Cell Lung Cancer: The Precision Medicine Phase II Randomized SAFIR02-Lung/IFCT 1301 TrialBarlesi F, Tomasini P, Karimi M et al. · Clinical cancer research : an official journal of the American Association for Cancer Research · 2022 · PMID 35802649
- Randomized controlled trial Combination of gefitinib and olaparib versus gefitinib alone in EGFR mutant non-small-cell lung cancer (NSCLC): A multicenter, randomized phase II study (GOAL)Garcia-Campelo R, Arrieta O, Massuti B et al. · Lung cancer (Amsterdam, Netherlands) · 2020 · PMID 33070053
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target BRCA1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Olaparib approved for Lung Cancer?
Olaparib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Lung Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Lung Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Olaparib in clinical trials for Lung Cancer?
ClinicalTrials.gov lists 8 registered trials linking Olaparib to Lung Cancer: 3 are currently recruiting; 2 are active or not yet recruiting; 2 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT03155620). It plans or enrolled 1377 participants. Registration activity spans 2016 to 2024.
What does the evidence show for Olaparib in Lung Cancer?
Olaparib has both completed registered trials and synthesis-level publications linked to Lung Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target BRCA1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.