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NCT07472517
DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemotherapy
Phase 3 trial testing obrixtamig in Small Cell Lung Cancer (SCLC) in 670 participants. Not yet recruiting.
10 September 2028
Quick facts
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 670 |
| Start date | 10 April 2026 |
| Primary completion | 10 September 2028 |
| Estimated completion | 31 July 2029 |
| Sites | 229 locations across Hong Kong, Italy, Finland, Japan, Malaysia, Taiwan, Ireland, Vietnam |
Drugs / interventions tested
- obrixtamig
- atezolizumab (atezolizumab) — full drug profile →
- carboplatin (Carboplatin) — full drug profile →
- etoposide (etoposide) — full drug profile →
Conditions studied
- Small Cell Lung Cancer (SCLC) — all drugs for Small Cell Lung Cancer (SCLC) →
- Extensive-stage Small Cell Lung Cancer (ES-SCLC) — all drugs for Extensive-stage Small Cell Lung Cancer (ES-SCLC) →
Sponsor
Boehringer Ingelheim — full company profile →
Who can join
18 and older, any sex, with Small Cell Lung Cancer (SCLC) or Extensive-stage Small Cell Lung Cancer (ES-SCLC). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is open to adults with advanced small cell lung cancer (SCLC). The purpose of this study is to find out if a study medicine called obrixtamig plus standard treatment (atezolizumab, carboplatin, and etoposide) improves survival when compared to standard treatment alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker DLL3. Participants are put into 2 groups randomly, which means by chance. One group receives obrixtamig and standard treatment. The other group receives standard treatment without obrixtamig. All treatments are given as infusions into a vein. Participants are in the study for up to 3 years. During this time, they visit the study site regularly. Participants in the group receiving obrixtamig stay overnight at the study site following the first 2 obrixtamig treatments. At the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07472517
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Small Cell Lung Cancer (SCLC)
Currently open trials in the same condition.
- NCT07480213 — Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lung Cancer (SCLC) · Phase 1, PHASE2 · recruiting
- NCT07434518 — A Real-World Study Evaluating the Efficacy and Safety of Adebrelimab in Patients With Advanced SCLC · recruiting
- NCT07510724 — Real-World Data on the Treatment of Lung Cancer Patients With the Immune-Checkpoint Inhibitor Tislelizumab · recruiting
- NCT07226999 — Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adul · Phase 2, PHASE3 · recruiting
- NCT06745323 — A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC · Phase 2 · active not recruiting
Other Boehringer Ingelheim trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07472517 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
- Last refreshed: 31 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07472517.
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