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Neo-adjuvant immunotherapy for Pancoast tumors

Phase II Clinical Trial of Neo-adjuvant Chemo/Immunotherapy Followed by Adjuvant Treatment Depending on the Resection Status for the Treatment of NSCLC Patients Diagnosed With Pancoast Tumor. A Multicenter Exploratory Study

Phase 2 Interventional Fundación GECP · NCT05684276

This study is testing whether a combination of immunotherapy and chemotherapy before surgery can help people with Pancoast tumors of lung cancer have better outcomes.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment22 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorFundación GECP Academic / other
Drugs / interventionsprednisone, nivolumab, chemotherapy, immunotherapy
Locations29 sites (Mataró, Barcelona and 28 other locations)
Trial IDNCT05684276 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a combination of immunotherapy and chemotherapy as a pre-surgical treatment for patients with non-small cell lung cancer (NSCLC) diagnosed with Pancoast tumors. Participants will receive Nivolumab, Paclitaxel, and Carboplatin over three cycles, followed by surgery and potential adjuvant treatment with Nivolumab. The study aims to determine the rate of complete tumor resection and assess overall and progression-free survival at 24 months. A total of 40 patients will be enrolled across multiple centers, with follow-up extending for two years post-treatment.

Who should consider this trial

Good fit: Ideal candidates are previously untreated adults aged 18 to 75 with histologically confirmed NSCLC and Pancoast tumors.

Not a fit: Patients with distant metastases or those who do not meet the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve surgical outcomes and survival rates for patients with Pancoast tumors.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in lung cancer, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 1. Previously untreated patients with histologically- or cytologically- documented NSCLC diagnosed with Pancoast tumor according to 8th edition of the TNM (stages IIB, IIIA and T3N2 (IIIB) patients)
* 2. PET/CT including IV contrast (CT of diagnostic quality) will be performed at baseline (28 days +10 before enrollment) to rule out the presence of distant disease. Also, a brain CT-SCAN or brain MRI will be done at baseline
* 3. Positive mediastinal lymph nodes by PET-CT must be confirmed histologically. Mediastinal involvement may be considered without the need for histological confirmation when there is a mass of lymph nodes in which the margins cannot be distinguished
* 4. Measurable or evaluable disease (according to RECIST 1.1 criteria)
* 5. ECOG (Performance status) 0-2
* 6. Patients with a life expectancy of at least more than 12 weeks
* 7. Patients aged \> 18 years and ≤ 75 years
* 8 Screening laboratory values must meet the study criteria and should be obtained within 14 days prior to enrollment
* 9. Correct lung function without bronchodilators, defined by forced expiratory volume in 1 second (FEV1) \>40% of the predicted normal volume, and a pulmonary diffusing capacity for carbon monoxide (DLCO) \>40% of the predicted normal value
* 10. All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention
* 11. Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before enrollment.
* 12. All sexually active men and women of childbearing potential must use an effective contraceptive method during the study treatment and for a period of at least 12 months following the last administration of trial drugs
* 13. Patient capable of proper therapeutic compliance and accessible for correct follow-up.

Exclusion Criteria:

* 1. Patients that receive previous treatment with antineoplastic drugs, chest radiotherapy, or previous surgery for lung cancer or for another reason
* 2. Pleural or pericardial effusion: Both will be considered indicative of metastatic disease unless proven otherwise. Those that, even being cytologically negative for malignancy, are exudates, will also be excluded. Patients with pleural effusion not visible on chest X-ray or too small to perform diagnostic puncture safely may be included.
* 3. Patients with a weight loss \>10% in the 3 months prior to the study entry
* 4. All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene or ROS1 mutations.
* 5. Patients with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included.
* 6. Patients with symptomatic neuropathy \> grade 1 according to the CTCAE v5.0 and that were not related to the tumor
* 7. Patients with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
* 8. Patients with a history of interstitial lung disease cannot be included if they have symptomatic ILD (Grade 3-4) and/or poor lung function. In case of doubt please contact trial team.
* 9. Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anticancer therapy
* 10. Patients with uncontrolled comorbidities that may affect the clinical trial compliance
* 11. Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 5 years prior to study entry and no additional therapy is required during the study period.
* 12. Any medical, mental, neurological or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information sheet.
* 13. Patients in any psychological, familiar, sociological or geographical situation that may hinder compliance with the study protocol and/or the follow up
* 14. Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
* 15. Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
* 16. Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
* 17. Patients with know hypersensitivity to drugs with a structure similar to the study drug and/or history of allergy to study drug components excipients
* 18. Women who are pregnant or in the period of breastfeeding
* 19. Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study

Where this trial is running

Mataró, Barcelona and 28 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 NSCLCPancoast TumorNeoadjuvant TreatmentNivolumab
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.