Necitumumab Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Necitumumab comprises 14 peer-reviewed publications across 8 journals, 2 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Carcinoma, Non-Small-Cell Lung. Most recent publication: Osimertinib plus datopotamab deruxtecan in patients with EGFR-mutated advanced NSCLC after progression on first-line osimertinib: ORCHARD., Ann Oncol, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Phase I Study of the Efficacy and Safety of Ramucirumab in Combination with Osimertinib in Advanced T790M-positive EGFR-mutant Non-small Cell Lung Cancer.
    Yu HA, Paz-Ares LG, Yang JC, et al. · Clin Cancer Res · 2022
    PubMed: PMID 33046516 · NCT02789345 · Carcinoma, Non-Small-Cell Lung
  2. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial.
    Thatcher N, Hirsch FR, Luft AV, et al. · Lancet Oncol · 2015
    PubMed: PMID 26045340 · NCT00981058 (SQUIRE) · Carcinoma, Non-Small-Cell Lung
  3. Targeting MET in EGFR resistance in non-small-cell lung cancer-ready for daily practice?
    Schmid S, Früh M, Peters S, et al. · Lancet Oncol · 2020
    PubMed: PMID 32027845 · NCT03944772 (ORCHARD) · Carcinoma, Non-Small-Cell Lung
  4. Osimertinib plus datopotamab deruxtecan in patients with EGFR-mutated advanced NSCLC after progression on first-line osimertinib: ORCHARD.
    Riess JW, Yu HA, Le X, et al. · Ann Oncol · 2026
    PubMed: PMID 41780641 · NCT03944772 (ORCHARD) · Carcinoma, Non-Small-Cell Lung
  5. ORCHARD: Osimertinib Plus Necitumumab in Patients With Epidermal Growth Factor Receptor-Mutated Advanced Non-Small Cell Lung Cancer With a Secondary Epidermal Growth Factor Receptor Alteration Whose Disease Had Progressed on First-Line Osimertinib.
    Riess JW, de Langen AJ, Ponce S, et al. · JCO Precis Oncol · 2025
    PubMed: PMID 40466026 · NCT03944772 (ORCHARD) · Carcinoma, Non-Small-Cell Lung
  6. Necitumumab plus pemetrexed and cisplatin as first-line therapy in patients with stage IV non-squamous non-small-cell lung cancer (INSPIRE): an open-label, randomised, controlled phase 3 study.
    Paz-Ares L, Mezger J, Ciuleanu TE, et al. · Lancet Oncol · 2015
    PubMed: PMID 25701171 · NCT00982111 (INSPIRE) · Carcinoma, Non-Small-Cell Lung
  7. Durvalumab Versus Chemotherapy as First-line Treatment for Metastatic NSCLC With Tumor PD-L1 Expression of 25% or Higher: Results From the Randomized Phase 3 PEARL Study.
    Lu S, Wu L, Wang Q, et al. · J Thorac Oncol · 2025
    PubMed: PMID 39521433 · NCT03944772 (ORCHARD) · Carcinoma, Non-Small-Cell Lung
  8. Osimertinib Plus Savolitinib in Patients With EGFR-Mutated Advanced NSCLC With MET Alterations After First-Line Osimertinib: Clinical Outcomes, Safety, and Biomarker Analysis: A Brief Report.
    Le X, Baik C, Cho BC, et al. · J Thorac Oncol · 2026
    PubMed: PMID 41130408 · NCT03944772 (ORCHARD) · Carcinoma, Non-Small-Cell Lung

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT00981058
SQUIRE
Carcinoma, Non-Small-Cell LungOverall Survival Time (OS)
Randomization to Death from Any Cause (Up to 31 Months)
Gemcitabine + Cisplatin9.9 Months
Necitumumab + Gemcitabine + Cisplatin11.5 Months
NCT00982111
INSPIRE
Carcinoma, Non-Small-Cell LungOverall Survival Time (OS)
Randomization to Death from Any Cause (Up to 31.6 Months)
Necitumumab + Pemetrexed + Cisplatin11.3 Months
Pemetrexed + Cisplatin11.5 Months

Publications by year

2015–2026: 14 publications.

2015
2
2017
2
2019
2
2020
1
2022
3
2025
2
2026
2

Publications by indication

Carcinoma, Non-Small-Cell Lung (12)

  • Osimertinib plus datopotamab deruxtecan in patients with EGFR-mutated advanced NSCLC after progression on first-line osimertinib: ORCHARD.
    Ann Oncol · 2026 · PMID 41780641 · NCT03944772
  • Osimertinib Plus Savolitinib in Patients With EGFR-Mutated Advanced NSCLC With MET Alterations After First-Line Osimertinib: Clinical Outcomes, Safety, and Biomarker Analysis: A Brief Report.
    J Thorac Oncol · 2026 · PMID 41130408 · NCT03944772
  • ORCHARD: Osimertinib Plus Necitumumab in Patients With Epidermal Growth Factor Receptor-Mutated Advanced Non-Small Cell Lung Cancer With a Secondary Epidermal Growth Factor Receptor Alteration Whose Disease Had Progressed on First-Line Osimertinib.
    JCO Precis Oncol · 2025 · PMID 40466026 · NCT03944772
  • Durvalumab Versus Chemotherapy as First-line Treatment for Metastatic NSCLC With Tumor PD-L1 Expression of 25% or Higher: Results From the Randomized Phase 3 PEARL Study.
    J Thorac Oncol · 2025 · PMID 39521433 · NCT03944772
  • Phase I Study of the Efficacy and Safety of Ramucirumab in Combination with Osimertinib in Advanced T790M-positive EGFR-mutant Non-small Cell Lung Cancer.
    Clin Cancer Res · 2022 · PMID 33046516 · NCT02789345

Publications by journal

Trial-results highlights

Clinical studies have explored the effectiveness of Necitumumab in patients diagnosed with Non-Small-Cell Lung Carcinoma. One such pivotal trial, known as SQUIRE (NCT00981058), investigated Overall Survival Time as its primary endpoint. This endpoint measured the duration from the time of randomization until death from any cause, for a period of up to 31 months. In the SQUIRE study, patients who received Necitumumab in combination with Gemcitabine and Cisplatin experienced a median Overall Survival Time of 11.5 Months. For those patients treated with Gemcitabine and Cisplatin alone, the median Overall Survival Time reported was 9.9 Months.

Another key study, INSPIRE (NCT00982111), also focused on patients with Non-Small-Cell Lung Carcinoma and evaluated Overall Survival Time. This trial assessed the duration from randomization to death from any cause, over a period of up to 31.6 months. In the INSPIRE study, the arm receiving Necitumumab alongside Pemetrexed and Cisplatin showed a median Overall Survival Time of 11.3 Months. In contrast, patients in the Pemetrexed + Cisplatin arm had a median Overall Survival Time of 11.5 Months.

All numeric values and findings presented are directly sourced from primary clinical trial registry reporting, and for comprehensive understanding and informed clinical decisions, it is recommended to consult the individual published papers and full study reports.

All Necitumumab publications (14)

2026 (2 papers)

  1. Osimertinib plus datopotamab deruxtecan in patients with EGFR-mutated advanced NSCLC after progression on first-line osimertinib: ORCHARD.
    Riess JW, Yu HA, Le X, et al. · Ann Oncol · 2026 · Derived
    PubMed: PMID 41780641 · NCT03944772 (ORCHARD) · Carcinoma, Non-Small-Cell Lung
  2. Osimertinib Plus Savolitinib in Patients With EGFR-Mutated Advanced NSCLC With MET Alterations After First-Line Osimertinib: Clinical Outcomes, Safety, and Biomarker Analysis: A Brief Report.
    Le X, Baik C, Cho BC, et al. · J Thorac Oncol · 2026 · Derived
    PubMed: PMID 41130408 · NCT03944772 (ORCHARD) · Carcinoma, Non-Small-Cell Lung

2025 (2 papers)

  1. ORCHARD: Osimertinib Plus Necitumumab in Patients With Epidermal Growth Factor Receptor-Mutated Advanced Non-Small Cell Lung Cancer With a Secondary Epidermal Growth Factor Receptor Alteration Whose Disease Had Progressed on First-Line Osimertinib.
    Riess JW, de Langen AJ, Ponce S, et al. · JCO Precis Oncol · 2025 · Derived
    PubMed: PMID 40466026 · NCT03944772 (ORCHARD) · Carcinoma, Non-Small-Cell Lung
  2. Durvalumab Versus Chemotherapy as First-line Treatment for Metastatic NSCLC With Tumor PD-L1 Expression of 25% or Higher: Results From the Randomized Phase 3 PEARL Study.
    Lu S, Wu L, Wang Q, et al. · J Thorac Oncol · 2025 · Derived
    PubMed: PMID 39521433 · NCT03944772 (ORCHARD) · Carcinoma, Non-Small-Cell Lung

2022 (3 papers)

  1. Phase I Study of the Efficacy and Safety of Ramucirumab in Combination with Osimertinib in Advanced T790M-positive EGFR-mutant Non-small Cell Lung Cancer.
    Yu HA, Paz-Ares LG, Yang JC, et al. · Clin Cancer Res · 2022 · Derived
    PubMed: PMID 33046516 · NCT02789345 · Carcinoma, Non-Small-Cell Lung
  2. Biomarker-Directed Phase II Platform Study in Patients With EGFR Sensitizing Mutation-Positive Advanced/Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed on First-Line Osimertinib Therapy (ORCHARD).
    Yu HA, Goldberg SB, Le X, et al. · Clin Lung Cancer · 2022 · Derived
    PubMed: PMID 34389237 · NCT03944772 (ORCHARD) · Carcinoma, Non-Small-Cell Lung
  3. Safety and preliminary activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab in patients with refractory solid tumors.
    Ochsenreither S, Fiedler WM, Conte GD, et al. · ESMO Open · 2022 · Derived
    PubMed: PMID 35397434 · NCT03360734 (GATTO)

2020 (1 paper)

  1. Targeting MET in EGFR resistance in non-small-cell lung cancer-ready for daily practice?
    Schmid S, Früh M, Peters S, et al. · Lancet Oncol · 2020 · Derived
    PubMed: PMID 32027845 · NCT03944772 (ORCHARD) · Carcinoma, Non-Small-Cell Lung

2019 (2 papers)

  1. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line treatment for stage IV squamous non-small cell lung cancer: A phase 1b and randomized, open-label, multicenter, phase 2 trial in Japan.
    Watanabe S, Yoshioka H, Sakai H, et al. · Lung Cancer · 2019 · Derived
    PubMed: PMID 30797492 · NCT01763788
  2. Efficacy and Safety of Necitumumab Continuation Therapy in the Phase III SQUIRE Study of Patients With Stage IV Squamous Non-Small-Cell Lung Cancer.
    Ciuleanu T, Socinski MA, Obasaju C, et al. · Clin Lung Cancer · 2019 · Derived
    PubMed: PMID 29158123 · NCT00981058 (SQUIRE) · Carcinoma, Non-Small-Cell Lung

2017 (2 papers)

  1. The Effect of Necitumumab in Combination with Gemcitabine plus Cisplatin on Tolerability and on Quality of Life: Results from the Phase 3 SQUIRE Trial.
    Reck M, Socinski MA, Luft A, et al. · J Thorac Oncol · 2017 · Derived
    PubMed: PMID 26980471 · NCT00981058 (SQUIRE) · Carcinoma, Non-Small-Cell Lung
  2. Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin plus necitumumab versus gemcitabine-cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer.
    Paz-Ares L, Socinski MA, Shahidi J, et al. · Ann Oncol · 2017 · Derived
    PubMed: PMID 27207107 · NCT00981058 (SQUIRE) · Carcinoma, Non-Small-Cell Lung

2015 (2 papers)

  1. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial.
    Thatcher N, Hirsch FR, Luft AV, et al. · Lancet Oncol · 2015 · Derived
    PubMed: PMID 26045340 · NCT00981058 (SQUIRE) · Carcinoma, Non-Small-Cell Lung
  2. Necitumumab plus pemetrexed and cisplatin as first-line therapy in patients with stage IV non-squamous non-small-cell lung cancer (INSPIRE): an open-label, randomised, controlled phase 3 study.
    Paz-Ares L, Mezger J, Ciuleanu TE, et al. · Lancet Oncol · 2015 · Derived
    PubMed: PMID 25701171 · NCT00982111 (INSPIRE) · Carcinoma, Non-Small-Cell Lung

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).