Clinical trial · Interventional
Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer
An Open-label, Randomized, Multicenter, Phase 1b/2b Trial Investigating the Safety and Preliminary Antitumor Effects of Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Symphogen made a business decision to no longer perform the clinical study
Summary
Brief summary (as posted)
This is a phase 1b/2b study investigating the safety and preliminary antitumor effects of Sym004 in combination with nivolumab versus nivolumab monotherapy when administered every second week.
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 |
|---|---|---|---|
| Squamous Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
| Sym004 | Drug | Futuximab/Modotuximab Mixture | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Sym004 + nivolumab
- description
- Phase 1b, dose-escalation: Dose Level 1: Sym004 + nivolumab (Q2W) Dose Level 2: Sym004 + nivolumab (Q2W) Dose Level -1: Sym004 + nivolumab, if needed
- interventionNames
- Drug: Sym004
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Sym004 (RP2D) + nivolumab
- description
- Phase 2b, dose-expansion: Receiving Sym004 in the RP2D in combination with nivolumab (Q2W)
- interventionNames
- Drug: Sym004
- Drug: Nivolumab
- type
- ACTIVE_COMPARATOR
- label
- Nivolumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Main Inclusion Criteria: * Signed and dated written informed consent * Male or female ≥18 years of age at the time of informed consent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy \>3 months assessed during Screening * Histologically or cytologically confirmed, locally advanced or metastatic squamous NSCLC Main Exclusion Criteria: * Any antineoplastic agent (standard or investigational) within 2 weeks prior to starting trial treatment * Radiosurgery or radiotherapy for target lesions within 2 weeks prior to starting trial treatment * Prophylactic use of hematopoietic growth factors within 1 week prior to starting trial treatment * Active Central Nervous System (CNS) metastases or carcinomatous meningitis * Women who are pregnant * Women who are breastfeeding
References
Publications (0)
Data not yet available