Necitumumab Clinical Trials (2026): 21 Studies for Metastatic Lung Non-Small Cell Carcinoma & Non Small Cell Lung Cancer
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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21 Necitumumab clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 18 indications (including Metastatic Lung Non-Small Cell Carcinoma & Non Small Cell Lung Cancer) and 3,043 total planned enrollment. 2 Phase 3 Necitumumab trials and 10 Phase 2 are listed. Most recent activity: NCT04285671 (Dec 2027).
Necitumumab clinical trials at a glance: phase × recruitment status
| Phase | active not recruiting | completed | terminated | withdrawn | Total |
|---|---|---|---|---|---|
| P1 | 1 | 4 | 1 | 6 | |
| P1/P2 | 1 | 1 | 1 | 3 | |
| P2 | 1 | 6 | 2 | 1 | 10 |
| P3 | 2 | 2 |
Necitumumab clinical trials by indication
Metastatic Lung Non-Small Cell Carcinoma (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04285671 | EGFR | P1/P2 | active not recruiting | Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer |
| NCT02496663 | — | P1 | active not recruiting | Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor |
Non-small Cell Lung Cancer (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02789345 | LY3009806 | P1 | completed | A Study of Ramucirumab (LY3009806) or Necitumumab (LY3012211) Plus Osimertinib in Participants With Lung Cancer |
| NCT01788566 | — | P2 | completed | A Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Participants With Squamous Lung Cancer |
Non Small Cell Lung Cancer (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00981058 | SQUIRE | P3 | completed | First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin |
| NCT00982111 | INSPIRE | P3 | completed | First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin |
Non-Small Cell Lung Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03944772 | ORCHARD | P2 | active not recruiting | Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) |
Squamous Cell Lung Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03574818 | — | P2 | terminated | Necitumumab in the Neoadjuvant Setting With Gemcitabine in Surgically Resectable - 14X-US-I001 |
Squamous Cell Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03387111 | SCC | P1/P2 | terminated | QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed |
Solid Tumor, Adult (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03360734 | GATTO | P1 | completed | Combination of Gatipotuzumab and Tomuzotuximab in Patients With Solid Tumors |
Non-Small Cell Lung Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03054038 | — | P1 | terminated | Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer |
Locally Advanced Squamous Non-Small Cell Lung Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02941601 | LY3012211 | P2 | withdrawn | A Study of Gemcitabine-Carboplatin Plus Necitumumab (LY3012211) in Chemotherapy-Naïve Participants With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) |
Carcinoma, Non-Small Cell Lung Cancer (NSCLC) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02392507 | LY3012211 | P2 | completed | A Study of Nab-Paclitaxel and Carboplatin Plus Necitumumab (LY3012211) in Participants With Stage IV Squamous NSCLC |
Stage IV Non-Small Cell Lung Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02451930 | LY3012211 | P1 | completed | A Study of the Combination of Necitumumab (LY3012211) and Pembrolizumab (MK3475) in Participants With NSCLC |
Non-small Cell Lung Cancer Metastatic (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02443337 | — | P2 | terminated | A Study of LY3023414 and Necitumumab in Squamous Lung Cancer |
Carcinoma, Non-Small-Cell Lung (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02411591 | NSCLC | P1 | completed | A Study of Necitumumab and Abemaciclib in Participants With Non-Small Cell Lung Cancer (NSCLC) |
Squamous Non-small Cell Lung Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01763788 | NSCLC | P1/P2 | completed | A Study of Necitumumab in the First-Line Treatment of Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) |
Squamous Non Small Cell Lung Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01769391 | — | P2 | completed | A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer |
Malignant Solid Tumor (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01606748 | IMC-11F8 | P2 | completed | A Drug-Interaction Study of Necitumumab (IMC-11F8) in Combination With Gemcitabine-Cisplatin |
Solid Tumors (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01624467 | — | P2 | completed | A Study of Necitumumab Monotherapy and the QT/QTc Interval in Patient With Advanced Solid Tumors |
Metastatic Colorectal Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00835185 | — | P2 | completed | Study of IMC-11F8 in Participants With Colorectal Cancer |
Necitumumab pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| SQUIRE | NCT00981058 | P3 | completed | Non Small Cell Lung Cancer | 1,093 | PMID 26045340 |
| INSPIRE | NCT00982111 | P3 | completed | Non Small Cell Lung Cancer | 633 | PMID 25701171 |
| ORCHARD | NCT03944772 | P2 | active not recruiting | Non-Small Cell Lung Cancer | 247 | PMID 34389237 |
| LY3012211 | NCT02392507 | P2 | completed | Carcinoma, Non-Small Cell Lung Cancer (NSCLC) | 54 | — |
| LY3012211 | NCT02941601 | P2 | withdrawn | Locally Advanced Squamous Non-Small Cell Lung Cancer | 0 | — |
| IMC-11F8 | NCT01606748 | P2 | completed | Malignant Solid Tumor | 35 | — |
Terminated and withdrawn Necitumumab trials (5)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT03054038terminatedAfatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer
- NCT03387111terminatedQUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed
- NCT03574818terminatedNecitumumab in the Neoadjuvant Setting With Gemcitabine in Surgically Resectable - 14X-US-I001
- NCT02941601withdrawnA Study of Gemcitabine-Carboplatin Plus Necitumumab (LY3012211) in Chemotherapy-Naïve Participants With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
- NCT02443337terminatedA Study of LY3023414 and Necitumumab in Squamous Lung Cancer
All Necitumumab trials (21)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT04285671 | EGFR | Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer | P1/P2 | active not recruiting | 30 | Jonsson Comprehensive Cancer Center | Jan 2021 |
| NCT02496663 | Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor | P1 | active not recruiting | 138 | National Cancer Institute (NCI) | May 2016 | |
| NCT03944772 | ORCHARD | Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) | P2 | active not recruiting | 247 | AstraZeneca | Jun 2019 |
| NCT00981058 | SQUIRE | First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin | P3 | completed | 1,093 | Eli Lilly and Company | Jan 2010 |
| NCT02789345 | LY3009806 | A Study of Ramucirumab (LY3009806) or Necitumumab (LY3012211) Plus Osimertinib in Participants With Lung Cancer | P1 | completed | 29 | Eli Lilly and Company | Oct 2016 |
| NCT03054038 | Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer | P1 | terminated | 22 | Vanderbilt-Ingram Cancer Center | Jul 2017 | |
| NCT03387111 | SCC | QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed | P1/P2 | terminated | 4 | ImmunityBio, Inc. | Jan 2018 |
| NCT00982111 | INSPIRE | First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin | P3 | completed | 633 | Eli Lilly and Company | Nov 2009 |
| NCT03360734 | GATTO | Combination of Gatipotuzumab and Tomuzotuximab in Patients With Solid Tumors | P1 | completed | 50 | Glycotope GmbH | Nov 2017 |
| NCT02392507 | LY3012211 | A Study of Nab-Paclitaxel and Carboplatin Plus Necitumumab (LY3012211) in Participants With Stage IV Squamous NSCLC | P2 | completed | 54 | Eli Lilly and Company | Oct 2015 |
| NCT03574818 | Necitumumab in the Neoadjuvant Setting With Gemcitabine in Surgically Resectable - 14X-US-I001 | P2 | terminated | 1 | Montefiore Medical Center | May 2018 | |
| NCT02451930 | LY3012211 | A Study of the Combination of Necitumumab (LY3012211) and Pembrolizumab (MK3475) in Participants With NSCLC | P1 | completed | 71 | Eli Lilly and Company | Sep 2015 |
| NCT02411591 | NSCLC | A Study of Necitumumab and Abemaciclib in Participants With Non-Small Cell Lung Cancer (NSCLC) | P1 | completed | 66 | Eli Lilly and Company | Jun 2015 |
| NCT02941601 | LY3012211 | A Study of Gemcitabine-Carboplatin Plus Necitumumab (LY3012211) in Chemotherapy-Naïve Participants With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) | P2 | withdrawn | 0 | Eli Lilly and Company | Nov 2016 |
| NCT01763788 | NSCLC | A Study of Necitumumab in the First-Line Treatment of Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) | P1/P2 | completed | 192 | Eli Lilly and Company | May 2013 |
| NCT02443337 | A Study of LY3023414 and Necitumumab in Squamous Lung Cancer | P2 | terminated | 31 | Eli Lilly and Company | Jul 2015 | |
| NCT01769391 | A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer | P2 | completed | 167 | Eli Lilly and Company | Jan 2013 | |
| NCT01606748 | IMC-11F8 | A Drug-Interaction Study of Necitumumab (IMC-11F8) in Combination With Gemcitabine-Cisplatin | P2 | completed | 35 | Eli Lilly and Company | Aug 2012 |
| NCT01788566 | A Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Participants With Squamous Lung Cancer | P2 | completed | 61 | Eli Lilly and Company | Mar 2013 | |
| NCT01624467 | A Study of Necitumumab Monotherapy and the QT/QTc Interval in Patient With Advanced Solid Tumors | P2 | completed | 75 | Eli Lilly and Company | Aug 2012 | |
| NCT00835185 | Study of IMC-11F8 in Participants With Colorectal Cancer | P2 | completed | 44 | Eli Lilly and Company | Aug 2007 |
Necitumumab clinical trials: frequently asked questions
- How many Necitumumab clinical trials are there?
- 21 Necitumumab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 13 are marked completed.
- Are Necitumumab clinical trials recruiting in 2026?
- No active Necitumumab trials are recruiting on ClinicalTrials.gov as of the current AACT refresh. Trials may resume; this page is updated daily.
- What conditions is Necitumumab being studied for?
- Necitumumab is being studied for Metastatic Lung Non-Small Cell Carcinoma, Non Small Cell Lung Cancer, Non-small Cell Lung Cancer, Malignant Solid Tumor, Metastatic Colorectal Cancer and 21 more. The trials are grouped by indication on this page.
- What phase is Necitumumab in?
- Necitumumab clinical trials span 2 Phase 3, 10 Phase 2, 6 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Necitumumab clinical trials?
- The lead sponsor across the most Necitumumab trials is Eli Lilly and Company, with 7 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Necitumumabas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
Related pages on Hipa.ai: