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Combining Tedopi with Docetaxel or Nivolumab for Lung Cancer Treatment

A Multicenter, Phase II, Open Label, Randomized Trial Evaluating the 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)

Phase 2 Interventional Fondazione Ricerca Traslazionale · NCT04884282

This study is testing if adding a new treatment called Tedopi to either docetaxel or nivolumab can help people with advanced lung cancer who haven't responded to previous treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment105 (estimated)
Ages18 Years and up
SexAll
SponsorFondazione Ricerca Traslazionale Academic / other
Drugs / interventionsimmunotherapy, radiation, prednisone, nivolumab
Locations23 sites (Avignon and 22 other locations)
Trial IDNCT04884282 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial evaluates the effectiveness of Tedopi in combination with either docetaxel or nivolumab as a second-line treatment for patients with metastatic non-small-cell lung cancer (NSCLC) who have progressed after first-line chemo-immunotherapy. Eligible patients, who must be HLA-A2 positive and have experienced disease progression after prior treatment, will be randomized into three arms: one receiving Tedopi with docetaxel, another receiving Tedopi with nivolumab, and a standard arm receiving docetaxel alone. The study aims to determine the efficacy of these combinations in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with HLA-A2 positive metastatic NSCLC who have progressed after first-line chemo-immunotherapy.

Not a fit: Patients with EGFR mutations or ALK or ROS1 rearrangements, as well as those with primary resistance to immunotherapy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could provide a new effective option for patients with advanced lung cancer who have limited treatment choices.

How similar studies have performed: While this approach is novel in its specific combination, similar studies have shown promise in using immunotherapy and chemotherapy together for lung cancer treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male and female patients willing and able to give written informed consent;
2. Histological or cytological confirmed diagnosis of HLA-A2+ NSCLC with no evidence of EGFR mutations or ALK or ROS1 rearrangement;
3. Evidence of disease progression at the end of at least 4 cycles of chemo-immunotherapy or 2 cycles of chemo-immunotherapy followed by 2 cycles of immunotherapy (CheckMate9LA regimen) and eligible for treatment with docetaxel. This criterion implies that patients with immunotherapy primary resistance are excluded;
4. Patients must have experienced progressive disease (PD), either during or within 3 months of discontinuing treatment with anti-PD-(L)1-based therapy, occurring after previous clear benefit (any complete -CR- or partial response -PR), or after previous stable disease (SD);
5. Performance status 0-1 (ECOG);
6. Patient compliance to trial procedures;
7. Age ≥ 18 years;
8. Adequate BM function (ANC ≥ 1.5x109/L, Platelets ≥ 100x109/L, HgB \> 9g/dl);
9. Adequate liver function (bilirubin \< G2, transaminases no more than 3xULN/\<5xULN in present of liver metastases);
10. Normal level of creatinine;
11. Female patient: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method \[complete abstinence, intrauterine contraceptive device (IUD), birth control pills, or barrier device\] until 5 months after end of treatment.

    or Male patient: should practice complete abstinence or if sexually active with WOCBP must use any contraceptive method with failure rate less than 1%/year and they should not donate semen as follows: in arm A and C until 6 months since the last dose of docetaxel; in arm B until 3 months since last dose of tedopi.
12. Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to treatment. Subjects with symptomatic tumor lesions that may require palliative radiotherapy within 4 weeks of first treatment are strongly encouraged to receive palliative radiotherapy prior to treatment. Patients are eligible if CNS metastases are adequately treated and patients are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization;
13. Patients must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization.

Exclusion Criteria:

1. Patient positive for actionable EGFR mutations or ALK or ROS1 rearrangement;
2. No previous chemoimmunotherapy for metastatic disease or evidence of disease progression during the first 4 cycles of chemoimmunotherapy (primary resistance). Patients with adjuvant resistance (documented loco-regionally and/or systemic relapse of their disease occurring \<6 months after the last dose of anti-PD-(L)1-based systemic adjuvant therapy) are excluded;
3. Patients with intervening systemic therapy following prior anti-PD-(L)1-based therapy;
4. Symptomatic brain metastases. Asymptomatic brain metastases are allowed if not requiring corticosteroids use at a dose \>10mg daily prednisone (or equivalent);
5. Diagnosis of any other malignancy during the last 3 years, except for in situ carcinoma of cervix uteri and cutaneous squamous cell carcinoma or other local tumors considered cured;
6. Pregnancy or lactating;
7. Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus; hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll;
8. Patients with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease;
9. Patients should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection;
10. Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).

Where this trial is running

Avignon and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Non Small Cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.