DUMAS: Neo-Adjuvant Immunotherapy for Pancoast Tumors

NCT05684276 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: GECP 22/02_DUMAS2022-003717-11
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 29

Brief Summary

The goal of this clinical trial is to test the efficacy of induction treatment of immunotherapy and chemotherapy depending on the resection status for the treatment of non small cell lung cancer patients diagnosed with pancoast tumor. The main objectives it aims to answer are:

• Complete resection rate after induction treatment with chemotherapy plus nivolumab
• Overall Survival and Progression Free Survival at 24 months The sample size is 40 patients.

Conditions

NSCLC; Pancoast Tumor

Keywords

Neoadjuvant Treatment; Nivolumab

Outcome Measures

Primary Outcomes (1)

• Estimate progression-free survival (PFS)

  The PFS is defined as the time from diagnosis to relapse, progression or death, whichever occurred first

  From the date randomization until the date of last follow up, assessed up to 24 months

Secondary Outcomes (3)

• Overall survival

  From the date of randomization until the date of last follow up, assessed up to 24 months

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  From the subject's written consent to participate in the study through 100 days after the final administration of the drug

• Complete resection (R0) rate

  From the date of completion of induction treatment until the date of last follow up, assessed up to 24 months

Study Arms (1)

Experimental: Neodjuvant treatment + Adjuvant maintenance treatment

EXPERIMENTAL

Neodjuvant treatment: Nivolumab: 360 mg intravenous Q3W Paclitaxel: 200mg/m2 infusion over 3 hours Carboplatin: AUC6 at the end of the Paclitaxel infusion Neoadjuvant treatment will start within 1-3 days from enrollment. 3 cycles will be administered at 21-day (+/- 3 days) intervals (QW3) prior to surgery. Before surgery a tumor assessment will be done. Patients must leave the study if there is evidence of progression. Patients with stable disease or partial response may be considered for surgery. Surgery: Surgery must be done within the 3rd-4th week (+7 days) from day 21 cycle 3 of neoadjuvant treatment (day 42-49 after day 1 of cycle 3) Depending on surgery results the patient will receive: * Patients with degree of resection 'R0': Adjuvant treatment for 6 months with Nivolumab 480mg QW4 * Patients with degree of resection 'R1' or 'R2': standard treatment according to local guidelines

Drug: Carboplatin; Drug: Paclitaxel; Drug: Nivolumab

Interventions

Carboplatin DRUG

Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, sodium chloride and glucose 5% solution solution or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin. Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of ech center.

Also known as: Paraplatin

Experimental: Neodjuvant treatment + Adjuvant maintenance treatment

Paclitaxel DRUG

Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexa-hydroxy-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine. Stability: Concentrations of 0.3-1.2 mg/ml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more that 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC. Guidelines on Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.

Also known as: Taxol

Experimental: Neodjuvant treatment + Adjuvant maintenance treatment

Nivolumab DRUG

Structure: Nivolumab is a soluble protein consisting of 4 polypeptide chains. Route of administration: Intravenous infusion. Product Description: Nivolumab (BMS-936558-01) Injection drug product is a sterile, non-pyrogenic, single-use, isotonic aqueous solution formulated in 10 mg/ml. Storage Conditions: It must be stored at 2 to 8 degrees Cº and protected from light and freezing. Guidelines: The administration of nivolumab infusion must be completed within 24 hours of preparation.The dose of Nivolumab for the adjuvant treatment is 360 mg administered as an intravenous infusion over 30 minutes every 3 weeks (+/-3 days) for 3 cycles. For the maintenance adjuvant treatment the dose is nivolumab 480 mg Q4W (+/-3 days) over 30 minutes for 6 months (6 cycles). Subjects should be carefully monitored during nivolumab administration to follow infusion reactions. Doses of nivolumab may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment.

Also known as: Opdivo

Experimental: Neodjuvant treatment + Adjuvant maintenance treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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)
• \. 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
• \. 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
• \. Measurable or evaluable disease (according to RECIST 1.1 criteria)
• \. ECOG (Performance status) 0-2
• \. Patients with a life expectancy of at least more than 12 weeks
• \. Patients aged \> 18 years and ≤ 75 years
• Screening laboratory values must meet the study criteria and should be obtained within 14 days prior to enrollment
• \. 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
• \. 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
• \. 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.
• \. 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
• \. Patient capable of proper therapeutic compliance and accessible for correct follow-up.

You may not qualify if:

• \. Patients that receive previous treatment with antineoplastic drugs, chest radiotherapy, or previous surgery for lung cancer or for another reason
• \. 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.
• \. Patients with a weight loss \>10% in the 3 months prior to the study entry
• \. All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene or ROS1 mutations.
• \. 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.
• \. Patients with symptomatic neuropathy \> grade 1 according to the CTCAE v5.0 and that were not related to the tumor
• \. 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.
• \. 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.
• \. Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anticancer therapy
• \. Patients with uncontrolled comorbidities that may affect the clinical trial compliance
• \. 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.
• \. 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.
• \. Patients in any psychological, familiar, sociological or geographical situation that may hinder compliance with the study protocol and/or the follow up
• \. 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
• \. 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

Sponsors & Collaborators

• Fundación GECP: lead

Study Sites (29)

Hospital General Universitario de Elche

Alicante, Alicante, 03203, Spain

Location

Hospital Universitari Quiron Dexeus

Barcelona, Barcelona, 08028, Spain

Location

Hospital Universitari Vall d' Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clínic De Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Parc Taulí

Barcelona, Barcelona, 08208, Spain

Location

Hospital De Mataro

Mataró, Barcelona, 08304, Spain

Location

Hospital Universitario de Cruces

Bilbao, Bilbao, 48903, Spain

Location

Hospital San Pedro De Alcántara

Cáceres, Cáceres, 10003, Spain

Location

Hospital Universitario Jerez De La Frontera

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Hospital Josep Trueta

Girona, Girona, 17007, Spain

Location

Hospital Universitario de Jaén

Jaén, Jaén, 23007, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, Lugo, 27003, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

Location

Hospital 12 De Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario la Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Fundació Althaïa

Manresa, Manresa, 08243, Spain

Location

Hospital Universitario Regional de Málaga

Málaga, Málaga, 29010, Spain

Location

Hospital Son Espases

Palma de Mallorca, Palma de Mallorca, 07120, Spain

Location

Hospital Universitario Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, Sevilla, 41013, Spain

Location

Consorci Sanitari de Terrassa

Terrassa, Terrassa, 08227, Spain

Location

Hospital Clínico de Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital General Universitario de Valencia

Valencia, Valencia, 46014, Spain

Location

Hospital Universitario Dr. Peset

Valencia, Valencia, 46017, Spain

Location

Hospital Universitario La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, 47003, Spain

Location

Complexo Hospitalario Universitario De Vigo

Vigo, Vigo, 36204, Spain

Location

Related Links

• Web page of the sponsor where users can find more information about Fundación GECP studies

MeSH Terms

Conditions

Pancoast Syndrome

Interventions

Carboplatin; Paclitaxel; Nivolumab

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mariano Provencio, MD

  Fundación GECP President

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 13, 2023
• Study Start: May 12, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (29)