Clinical trial · Interventional
Volrustomig Priming Regimens Exploratory Phase II Platform Study
A Phase II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Volrustomig Priming Regimens in Combination With Other Anticancer Agents in Participants With Solid Tumors (eVOLVE-01)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of volrustomig in combination with other anticancer drugs in participants with specified solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Ramucirumab | Drug | Ramucirumab | ALIAS |
| Volrustomig | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Substudy 1: Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed
- description
- Volrustomig priming dose followed by volrustomig dosing regimen 1 in combination with carboplatin and pemetrexed.
- interventionNames
- Drug: Volrustomig
- Drug: Carboplatin
- Drug: Pemetrexed
- type
- EXPERIMENTAL
- label
- Substudy 1: Arm 1B: Volrustomig dose regimen 2 + Carboplatin and Pemetrexed
- description
- Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with carboplatin and pemetrexed.
- interventionNames
- Drug: Volrustomig
- Drug: Carboplatin
- Drug: Pemetrexed
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration. * Life expectancy greater than or equal to (\>=) 12 weeks. * Adequate organ and bone marrow function. * Body weight greater than (\>) 35 kilograms (kg) at screening and at randomization. * Histologically or cytologically documented NSQ NSCLC in substudy 1 and SQ or NSQ mNSCLC in substudy 2. * Absence of sensitizing epidermal growth factor receptor (EGFR) mutations. * Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies. * At least one measurable lesion not previously irradiated that can be accurately measured at baseline as \>= 10 millimeter (mm) in the longest diameter. Key Exclusion Criteria: * Spinal cord compression. * History of primary active immunodeficiency. * Active or prior documented autoimmune or inflammatory disorders. * Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. * Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of radiation therapy and study enrollment. * Prior chemotherapy or any other systemic therapy for Stage IV NSCLC. Participants who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for local disease are eligible, provided that progression has occurred greater (\>) 12 months from end of last therapy.
References
Publications (0)
Data not yet available