At a glance
ClinicalIndex Comparison Record- ✓Limited- or extensive-disease SCLC at diagnosis with relapse at study entry and measurable disease per RECIST 1.1; both platinum-sensitive and platinum-resistant patients eligible
- ✓Extrapulmonary small cell cancers (small cell morphology arising outside the lung, e.g., small cell prostate, bladder) eligible for exploratory cohort
- ✓Age ≥18 years
- ✓ECOG performance status ≤2 (Karnofsky ≥60%)
- ✕Prior topotecan therapy
- ✕Symptomatic brain metastases
- ✕Chemotherapy or radiotherapy within 3 weeks prior to enrollment (exception: palliative radiotherapy allowed if recovered with ≥1 week interval)
- ✕Unrecovered adverse events from prior anti-cancer therapy (residual toxicities >grade 1, except hair loss and peripheral neuropathy)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase II Trial of Topotecan Plus M6620 (VX-970, Berzosertib) Vs. Topotecan Alone in Patients With Relapsed Small-Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating Berzosertib, Biopsy Procedure, and 3 other interventions for Extensive Stage Lung Small Cell Carcinoma and 5 related conditions. Active but no longer recruiting, targeting 104 participants across 33 sites.
Signals
Detailed Summary
This phase II trial studies how well berzosertib (M6620) works when given in combination with topotecan hydrochloride (topotecan) compared with topotecan alone in treating patients with small cell lung cancer that has come back (relapsed), or small cell cancer that arises from a site other than the lung (extrapulmonary). Drugs used in chemotherapy, such as topotecan hydrochloride, work by damaging the DNA (deoxyribonucleic acid) in tumor cells, causing those cells to die and the tumor to shrink. However, some tumor cells can become less affected by chemotherapy because they have ways to repair the damaged DNA. The addition of M6620 could help topotecan hydrochloride shrink the cancer and prevent it from returning by blocking enzymes needed for DNA repair.
Study Details
Timeline
Arms & Interventions
Participants receive topotecan hydrochloride IV over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants may crossover to Arm II at disease progression. Participants undergo a CT scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.
Participants receive topotecan hydrochloride IV over 30 minutes on days 1-5 and berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a CT scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.
Cohort II: Participants receive topotecan hydrochloride IV over 30 minutes on days 1-5 and berzosertib (M6620) IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo a CT scan during screening and on study as well as a tumor biopsy during screening. Participants may also undergo blood sample collection during screening and on study.
Interventions
Given IV
Undergo a tumor biopsy
Undergo blood sample collection
Undergo a CT scan
Given IV