Testing the Safety of M6620 (VX-970) When Given With Standard Whole Brain Radiation Therapy for the Treatment of Brain Metastases From Non-small Cell Lung Cancer, Small Cell Lung Cancer, or Neuroendocrine Tumors
Active, enrolledPhase 1Results postedLast updated 8 October 2025
What this trial tests
Phase 1 trial testing Berzosertib in Metastatic Lung Neuroendocrine Neoplasm in 15 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, any sex, with Metastatic Lung Neuroendocrine Neoplasm or Metastatic Lung Non-Small Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With a Dose-limiting ToxicityPrimary· Up to 3 weeks after completing whole brain radiotherapy (WBRT)
Defined as any grade 3 or more non-hematological toxicity requiring more than 5 day interruption in therapy or any grade 4 or higher hematological toxicity that is attributable to the berzosertib (M6620 \[VX-970\]) and/or whole brain radiotherapy
Group
Value
95% CI
Group 1 - Dose Level 1
2
Group 1 - Dose Level 2
0
Group 1 - Dose Level 1
7
Group 1 - Dose Level 2
2
Radiological Response RateSecondary· 6 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) is \>=30% decrease in the sum of the target lesions; Disease Progression (PD) is \>= 20% increase in the smallest sum of the target lesions; Stable Disease (SD) is between PR and PD.
Group
Value
95% CI
Group 1 - Dose Level 1
0
Group 1 - Dose Level 2
0
Group 1 - Dose Level 1
0
Group 1 - Dose Level 2
0
Group 1 - Dose Level 1
3
Group 1 - Dose Level 2
0
Group 1 - Dose Level 1
6
Group 1 - Dose Level 2
1
Overall Survival (OS)Secondary· 12 months
Kaplan-Meier estimates of OS will be calculated. For calculation of OS, patients alive at last follow-up will be censored. Exploratory Cox regression analysis with M6620 (VX-970) dose as a covariate will be performed.
Group
Value
95% CI
Group 1 - Dose Level 1
2
Group 1 - Dose Level 2
0
Group 1 - Dose Level 1
6
Group 1 - Dose Level 2
0
Group 1 - Dose Level 1
0
Group 1 - Dose Level 2
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 2 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase I trial studies the side effects and best dose of berzosertib (M6620 \[VX-970\]) when given together with whole brain radiation therapy in treating patients with non-small cell lung cancer, small cell lung cancer, or neuroendocrine tumors that have spread from the original (primary) tumor to the brain (brain metastases). Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving berzosertib together with radiation therapy may work better compared to standard of care treatment, including brain surgery and radiation therapy, in treating patients with non-small cell lung cancer, small cell lung cancer, or neuroendocrine tumors.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05246111 — Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)
· Phase 1
· completed
NCT04826341 — A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuro
· Phase 1, PHASE2
· recruiting
NCT04802174 — Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High-Grade Neuroendocrine Cancers
· Phase 1, PHASE2
· active not recruiting
NCT04216316 — Testing the Addition of an Anti-cancer Drug, Berzosertib (M6620, VX-970), to the Usual Treatments (Carboplatin and Gemci
· Phase 1, PHASE2
· active not recruiting
NCT04768296 — Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250)
· Phase 2
· completed
Other recruiting trials for Metastatic Lung Neuroendocrine Neoplasm
Currently open trials in the same condition.
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· recruiting
NCT03375320 — Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
· Phase 3
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 8 October 2025
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/NCT02589522.