ArticleBMC cancer2020
Ipilimumab plus nivolumab and chemoradiotherapy followed by surgery in patients with resectable and borderline resectable T3-4N0-1 non-small cell lung cancer: the INCREASE trial.
Article in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.
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Who cites it
28 citing papers in PubMed, 38 citations in OpenAlex.
- Single-arm trial of neoadjuvant ipilimumab plus nivolumab with chemoradiotherapy in patients with resectable and borderline resectable lung cancer: the INCREASE study.Journal for immunotherapy of cancer · 2024Trial
- Opportunities and challenges of immunotherapy for patients with resectable and potentially resectable stage III non-small cell lung cancer.Cancer biology & medicine · 2026Review
- Neoadjuvant and perioperative immunotherapy in resectable non-small cell lung cancer: Evidence to date and remaining questions.JTCVS open · 2026Article
- Advances in neoadjuvant immunotherapy for non-small cell lung cancer.Frontiers in immunology · 2026Review
- Immune-modulating effects on tumor-draining lymph nodes of neoadjuvant chemoradiotherapy combined with dual immunotherapy in patients with T3-4N0-2 NSCLC.Journal for immunotherapy of cancer · 2025Observational
- Review
- Combination Immunotherapy With Radiotherapy in Non-Small Cell Lung Cancer: A Review of Evidence.Cancer medicine · 2024Review
- Stage III NSCLC treatment options: too many choices.Breathe (Sheffield, England) · 2024Review
- Defining resectability: When do you try to take it out?JTCVS open · 2024Article
- An Updated Review of Management of Resectable Stage III NSCLC in the Era of Neoadjuvant Immunotherapy.Cancers · 2024Review
- Superior Sulcus Tumors Invading the Spine: Multimodal Treatment Outcomes From the Preimmunotherapy Era.JTO clinical and research reports · 2023Article
- Risk factors and a prognostic model for patients with borderline resectable locally advanced T3-4N0-1 non-small cell lung cancer: a population-based study.Translational cancer research · 2023Article
- Recent Advances in Perioperative Immunotherapies in Lung Cancer.Biomolecules · 2023Review
- Current Approaches to Neoadjuvant Immunotherapy in Resectable Non-small Cell Lung Cancer.Current oncology reports · 2023Review
- Surgical Approaches to Pancoast Tumors.Journal of personalized medicine · 2023Review
- Neoadjuvant immune checkpoint inhibitor treatment + chemotherapy (vs. chemotherapy alone) for locally advanced non‑small cell lung cancer: A retrospective cohort study.Oncology letters · 2023Article
- Long-Term Outcomes After Chemoradiotherapy and Surgery for Superior Sulcus Tumors.JTO clinical and research reports · 2023Article
- Anatomic lung resection after immune checkpoint inhibitors for initially unresectable advanced-staged non-small cell lung cancer: a retrospective cohort analysis.Journal of thoracic disease · 2023Article
- Neoadjuvant chemo-immunotherapy for lung cancer: how much is too much?Translational lung cancer research · 2022Article
- Recent advances in postoperative pulmonary rehabilitation of patients with non‑small cell lung cancer (Review).International journal of oncology · 2022Review
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Authors and funding
16 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe likelihood of a tumor recurrence in patients with T3-4N0-1 non-small cell lung cancer following multimodality treatment remains substantial, mainly due distant metastases. As pathological complete responses (pCR) in resected specimens are seen in only a minority (28-38%) of patients following chemoradiotherapy, we designed the INCREASE trial (EudraCT-Number: 2019-003454-83; Netherlands Trial Register number: NL8435) to assess if pCR rates could be further improved by adding short course immunotherapy to induction chemoradiotherapy. Translational studies will correlate changes in loco-regional and systemic immune status with patterns of recurrence. METHODS/
designThis single-arm, prospective phase II trial will enroll 29 patients with either resectable, or borderline resectable, T3-4N0-1 NSCLC. The protocol was approved by the institutional ethics committee. Study enrollment commenced in February 2020. On day 1 of guideline-recommended concurrent chemoradiotherapy (CRT), ipilimumab (IPI, 1 mg/kg IV) and nivolumab (NIVO, 360 mg flat dose IV) will be administered, followed by nivolumab (360 mg flat dose IV) after 3 weeks. Radiotherapy consists of once-daily doses of 2 Gy to a total of 50 Gy, and chemotherapy will consist of a platinum-doublet. An anatomical pulmonary resection is planned 6 weeks after the last day of radiotherapy. The primary study objective is to establish the safety of adding IPI/NIVO to pre-operative CRT, and its impact on pathological tumor response. Secondary objectives are to assess the impact of adding IPI/NIVO to CRT on disease free and overall survival. Exploratory objectives are to characterize tumor inflammation and the immune contexture in the tumor and tumor-draining lymph nodes (TDLN), and to explore the effects of IPI/NIVO and CRT and surgery on distribution and phenotype of peripheral blood immune subsets. DISCUSSION: The INCREASE trial will evaluate the safety and local efficacy of a combination of 4 modalities in patients with resectable, T3-4N0-1 NSCLC. Translational research will investigate the mechanisms of action and drug related adverse events.
trial registrationNetherlands Trial Registration (NTR): NL8435 , Registered 03 March 2020.
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