Clinical trial · Interventional
A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
A Phase 2, Randomized, Open-label, Study Assessing the Safety, Tolerability and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the safety, tolerability, and efficacy of Imzokitug in combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as first-line treatment for participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Non-Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Non-Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Imzokitug | Drug | — | UNRESOLVED |
| Infliximab | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Pumitamig | Drug | — | UNRESOLVED |
| Vedolizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm A: Pumitamig + Imzokitug + Histology-based PDCT
- interventionNames
- Drug: Pumitamig
- Drug: Imzokitug
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Paclitaxel
- Drug: Infliximab
- Drug: Vedolizumab
- type
- EXPERIMENTAL
- label
- Arm B: Pumitamig + Imzokitug + Histology-based PDCT
- interventionNames
- Drug: Pumitamig
- Drug: Imzokitug
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Paclitaxel
- Drug: Infliximab
- Drug: Vedolizumab
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Participants must have histologically confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) (squamous or non-squamous) or recurrent unresectable disease per the American joint committee on cancer (AJCC) Staging System 9th edition. * Participants must have no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease. * Tumor tissue (fresh or archival) obtained within 5 months of enrollment (signing of informed consent) for each participant must be submitted by the site. * Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Exclusion Criteria * Participants must not have any documented actionable genomic alterations (AGAs) for which first line approved targeted therapies are indicated. * Participants must not have prior treatment with immuno-oncology therapies. * Participants must not have untreated central nervous system (CNS) metastases. * Other protocol-defined Inclusion/Exclusion criteria apply.
References
Publications (0)
Data not yet available