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An Open Label Multicenter Phase 1b Study with Expansion Cohorts to Evaluate Safety and Efficacy of the Combination of Necitumumab with Pembrolizumab in Patients with Stage IV Non Small Cell Lung Cancer and Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (I4X-MC-JFCQ)

An Open Label Multicenter Phase 1b Study with Expansion Cohorts to Evaluate Safety and Efficacy of the Combination of Necitumumab with Pembrolizumab in Patients with Stage IV Non Small Cell Lung Cancer and Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (I4X-MC-JFCQ)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223316
Enrollment
Unknown
Registered
2016-09-06
Start date
2016-09-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IV Non-Small Cell Lung Cancer

Interventions

investigational material(s) Generic name etc : necitumumab INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational mater

Sponsors

Eli Lilly Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -NSCLC Stage IV (squamous and nonsquamous) -The patient must have progressed after 1 platinum-based chemotherapy regimen. Prior therapy with VEGF/VEGFR targeting agents is permitted. Prior neoadjuvant/adjuvant therapy is permitted. Prior treatment with EGFR-TKI and ALK inhibitors is mandatory in patients with NSCLC whose tumor has EGFR-activating mutations or ALK translocations, respectively. -Measurable disease at the time of study entry as defined by Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). -The participant has tumor tissue available for biomarker analyses. -The participant has adequate organ function. -Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1

Exclusion criteria

Exclusion criteria:

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026