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New combo therapy aims to shrink Hard-to-Treat lung tumors before surgery

NCT ID NCT05684276

Disease control Sponsor: Fundación GECP Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests giving chemotherapy (carboplatin and paclitaxel) plus the immunotherapy drug nivolumab before surgery for people with Pancoast tumors, a rare type of lung cancer. After surgery, additional treatment is tailored based on whether the tumor was fully removed. The study aims to see if this approach helps more patients achieve complete tumor removal and improves survival. About 22 patients are enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Carboplatin, Paclitaxel, and Nivolumab
What this could lead to
If successful, this approach could improve the chances of complete tumor removal and extend survival for people with this rare lung cancer.
What could go wrong
This is a small, early-phase trial with only 22 participants, so results may not apply broadly. Chemo and immunotherapy can cause serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

lung superior sulcus carcinoma malignant superior sulcus neoplasm non-small cell lung carcinoma Pancoast syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NSCLC Pancoast tumor

Contacts and locations

Locations

  • Complexo Hospitalario Universitario De Vigo

    Vigo, Vigo, 36204, Spain

  • Consorci Sanitari de Terrassa

    Terrassa, Terrassa, 08227, Spain

  • Fundació Althaïa

    Manresa, Manresa, 08243, Spain

  • Hospital 12 De Octubre

    Madrid, Madrid, 28041, Spain

  • Hospital Clínic De Barcelona

    Barcelona, Barcelona, 08036, Spain

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040, Spain

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Valladolid, 47003, Spain

  • Hospital Clínico de Valencia

    Valencia, Valencia, 46010, Spain

  • Hospital De Mataro

    Mataró, Barcelona, 08304, Spain

  • Hospital General Universitario de Elche

    Alicante, Alicante, 03203, Spain

  • Hospital General Universitario de Valencia

    Valencia, Valencia, 46014, Spain

  • Hospital Josep Trueta

    Girona, Girona, 17007, Spain

  • Hospital Parc Taulí

    Barcelona, Barcelona, 08208, Spain

  • Hospital San Pedro De Alcántara

    Cáceres, Cáceres, 10003, Spain

  • Hospital Son Espases

    Palma de Mallorca, Palma de Mallorca, 07120, Spain

  • Hospital Universitari Quiron Dexeus

    Barcelona, Barcelona, 08028, Spain

  • Hospital Universitari Vall d' Hebron

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario Dr. Peset

    Valencia, Valencia, 46017, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Madrid, 28040, Spain

  • Hospital Universitario Jerez De La Frontera

    Jerez de la Frontera, Cádiz, 11407, Spain

  • Hospital Universitario La Fe

    Valencia, Valencia, 46026, Spain

  • Hospital Universitario Lucus Augusti

    Lugo, Lugo, 27003, Spain

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Regional de Málaga

    Málaga, Málaga, 29010, Spain

  • Hospital Universitario Salamanca

    Salamanca, Salamanca, 37007, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, Sevilla, 41013, Spain

  • Hospital Universitario de Cruces

    Bilbao, Bilbao, 48903, Spain

  • Hospital Universitario de Jaén

    Jaén, Jaén, 23007, Spain

  • Hospital Universitario la Paz

    Madrid, Madrid, 28046, Spain

More trials for these conditions

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