Clinical trial · Interventional
A Study of HLX07 + HLX10 With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC
A Randomized, Open-Label, Multicenter, Phase II Study of HLX07 (Anti-EGFR Antibody) +HLX10 (Anti-PD-1 Antibody) With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC
- 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)
The purpose of this study is to evaluate the clinical efficacy and safety of HLX07 In Combination with HLX10 with or without Chemotherapy versus HLX10 with Chemotherapy in First Line Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.
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 | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HLX10+chemo | Drug | — | UNRESOLVED |
| HLX10+HLX07 | Drug | — | UNRESOLVED |
| HLX10+HLX07+chemo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- A arm: HLX10+chemo
- description
- Participants receive 300mg HLX10 IV every 3 weeks (Q3W) in combination with carboplaitin (AUC5 or 6) IV Q3W and nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle.
- interventionNames
- Drug: HLX10+chemo
- type
- EXPERIMENTAL
- label
- B arm: HLX10+HLX07+chemo
- description
- Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W with chemo.
- interventionNames
- Drug: HLX10+HLX07+chemo
- type
- EXPERIMENTAL
- label
- C arm: HLX10+HLX07
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of previously untreated, Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer * EGFR immunohistochemistry (IHC) H score ≥200 assessed by central lab * Has measurable disease as defined by RECIST 1.1 as determined by the IRRC * Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale * Has a life expectancy of greater than 12 weeks * Has adequate organ function Exclusion Criteria: * Histologically non-squamous NSCLC must be exclused. For non-small-cell histology, if has squamous components be allowed * Has history of such as PD-1/PD-L1、EGFR、 CTLA4 targeted therapy * EGFR sensitivity mutation or ALK or ROS1 gene rearrangement need to be excluded * Has had other active malignancies within 5 years or at the same time * Has uncontrolled pleural effusion、pericardial effusion or ascites
References
Publications (0)
Data not yet available