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Abstract
Despite the positive results obtained by first-line chemoimmunotherapy in patients with metastatic non-small-cell lung cancer (NSCLC), only a few second-line options are available after disease progression. Combi-TED is a phase II international study that will assess the efficacy of Tedopi®, a cancer vaccine, combined with either docetaxel or nivolumab and compared with docetaxel monotherapy in patients with metastatic NSCLC after chemoimmunotherapy. The study, currently in the recruitment phase, will assess 1-year overall survival (primary end point), patient's progression-free survival and overall response rate, as well as the correlation of efficacy with several tumor or blood biomarkers. The results will hopefully provide more information on Tedopi combinational treatment compared with current standard of care in NSCLC patients who fail first-line chemoimmunotherapy.
Clinical Trial Registration: NCT04884282 (ClinicalTrials.gov)
Plain language summary
Patients with lung cancer that has spread to other parts of the body are usually treated with a combination of chemotherapy and drugs that stimulate the immune system to kill cancer cells, which is referred to as immunotherapy. If after receiving these drugs the cancer still gets worse, patients have only a few treatment options left and are usually treated with chemotherapy only. Researchers will study if a new medicine called Tedopi®, a vaccine that specifically attacks cancer cells, used together with chemotherapy or immunotherapy, will work better then chemotherapy alone for these patients. The study will monitor how long patients will live after treatment, for how long they will live without their disease getting worse and how many patients will improve after treatment. Moreover, researchers will study if patients present specific features, such as certain molecules in their tumor cells or blood cells, that may indicate that they respond better to certain treatments.
Tweetable abstract
Researchers will study how patients with lung cancer that progressed after first-line will respond to a combination of a cancer-vaccine (Tedopi®) plus chemotherapy or immunotherapy compared with chemotherapy alone. #lungcancer #vaccine
Supplementary data
To view the supplementary data that accompany this paper please visit the journal website at: www.futuremedicine.com/doi/suppl/10.2217/fon-2022-0913
Author contributions
Study conception and design: F Cappuzzo, L Landi. Collection and interpretation of data: all authors. Statistical analysis: D Giannarelli. Manuscript drafting: F Cappuzzo, L Landi. Manuscript editing: All authors. Approval to submit: all authors.
Acknowledgments
Medical writing and editorial assistance were provided by A Corti, V Attanasio and A Shah (Polistudium, srl), which were supported by internal funds.
Financial & competing interests disclosure
The study is funded by Fondazione Ricerca Traslazionale (FoRT). G Pasello is an Advisor/Consultant for AstraZeneca, Lilly, MSD, Roche, Takeda and Novartis. He received unconditioned research support from AstraZeneca and Roche. The other authors have no conflicts of interest to declare. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
Ethics conduct of research
The study was approved by the Comitato Etico Centrale IRCCS Lazio – Sezione I.F.O. Fondazione Bietti. No results are presented in this article. All the patients will sign an informed consent form before participation in the trial.
Notes
CR: Complete response; ECOG: Eastern Cooperative Oncology Group; NSCLC: Non-small-cell lung cancer; PD: Progressive disease; PR: Partial response; SD: Stable disease.