Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED)

Summary

This is a phase II, non-comparative, randomized study assessing combination of Tedopi with docetaxel or with nivolumab in NSCLC patients failing after first- line chemoimmunotherapy. In this non-comparative study, the standard arm (arm C) will serve as a calibration arm. All NSCLC patients candidate for second- line therapy are considered eligible for the study if they are HLA-A2+ and if they progressed after at least 4 cycles of previous first-line chemo-immunotherapy. After evaluation of all inclusion and exclusion criteria and after informed consent signature, all eligible patients will be treated with Tedopi plus docetaxel (arm A) or Tedopi plus nivolumab (arm B) or docetaxel as single agent (arm C- standard arm). Docetaxel therapy will be given until disease progression, unacceptable toxicity or patient refusal, and up to maximum 6 cycles. Tedopi or nivolumab will be given until disease progression, unacceptable toxicity or patient refusal.

Timeline

Start

2021-10-12

Primary completion

2027-09-30

Completion

2028-09-30

Publications

• Landi L, Delmonte A, Bonetti A, Pasello G, Metro G, Mazzoni F, Borra G, Giannarelli D, Andrikou K, Mangiola D, Gori S, D'Andrea MR, Minuti G, Resuli B, Laudisi A, Vidiri A, Conti L, Cappuzzo F. Combi-TED: a new trial testing Tedopi(R) with docetaxel or nivolumab in metastatic non-small-cell lung cancer progressing after first line. Future Oncol. 2022 Dec;18(40):4457-4464. doi: 10.2217/fon-2022-0913. Epub 2023 Mar 22.

Drugs

Indications