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NSCLCPhase 2DUMASNCT05684276

DUMAS: Neo-Adjuvant Immunotherapy for Pancoast Tumors

A Phase 2 study testing Carboplatin, Paclitaxel and Nivolumab in people with NSCLC and Pancoast Tumor, run by Fundación GECP at 29 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NSCLC, Pancoast Tumor
What is being tested?
Carboplatin, Paclitaxel and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
29 sitesSpain
Study dates
12 May 2023to 1 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

Spain29 sites

  • Hospital General Universitario de Elche

    Alicante, Alicante, 03203

  • Hospital Universitari Quiron Dexeus

    Barcelona, Barcelona, 08028

  • Hospital Universitari Vall d' Hebron

    Barcelona, Barcelona, 08035

  • Hospital Clínic De Barcelona

    Barcelona, Barcelona, 08036

  • Hospital Parc Taulí

    Barcelona, Barcelona, 08208

  • Hospital Universitario de Cruces

    Bilbao, Bilbao, 48903

  • Hospital San Pedro De Alcántara

    Cáceres, Cáceres, 10003

  • Hospital Josep Trueta

    Girona, Girona, 17007

  • Hospital Universitario de Jaén

    Jaén, Jaén, 23007

  • Hospital Universitario Jerez De La Frontera

    Jerez de la Frontera, Cádiz, 11407

  • Hospital Universitario Lucus Augusti

    Lugo, Lugo, 27003

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Madrid, 28040

  • Hospital 12 De Octubre

    Madrid, Madrid, 28041

  • Hospital Universitario la Paz

    Madrid, Madrid, 28046

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Universitario Regional de Málaga

    Málaga, Málaga, 29010

  • Fundació Althaïa

    Manresa, Manresa, 08243

  • Hospital De Mataro

    Mataró, Barcelona, 08304

  • Hospital Son Espases

    Palma de Mallorca, Palma de Mallorca, 07120

  • Hospital Universitario Salamanca

    Salamanca, Salamanca, 37007

  • Hospital Universitario Virgen Del Rocio

    Seville, Sevilla, 41013

  • Consorci Sanitari de Terrassa

    Terrassa, Terrassa, 08227

  • Hospital Clínico de Valencia

    Valencia, Valencia, 46010

  • Hospital General Universitario de Valencia

    Valencia, Valencia, 46014

  • Hospital Universitario Dr. Peset

    Valencia, Valencia, 46017

  • Hospital Universitario La Fe

    Valencia, Valencia, 46026

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Valladolid, 47003

  • Complexo Hospitalario Universitario De Vigo

    Vigo, Vigo, 36204

Other trials in Spain

About this study

Official title: 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

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.

Read the detailed description

This is an open-label, phase II, single-arm, multi-centre clinical trial.

The total sample size is 40 patients. The population to be included are previously untreated patients with histologically- or cytologically- documented NSCLC diagnosed with Pancoast tumor.

Patients will receive Nivolumab 360mg + Paclitaxel 200mg/m2 + Carboplatin AUC6 for 3 cycles every 21 days (+/- 3 days) as neoadjuvant treatment followed by surgery and 6 months of adjuvant treatment with Nivolumab 480 mg Q4W (+/- 3 days) if applicable and depending on surgery results. Patients that will not receive adjuvant treatment will start follow up phase after end of treatment visit. Follow up for all patients must be done for 2 years.

The primary objective is to evaluate the complete resection (R0) rate after induction treatment defined as the absence of residual tumor in patients treated with neoadjuvant chemo-immunotherapy.Secondary objectives and endpoint are Overall survival rate at 24 months and disease-free survival rate at 24 months.

Patient accrual is expected to be completed within 2 years excluding a run-in-period of 3 months. Treatment and follow-up are expected to extend the study duration to a total of 5 years. The study will end once survival follow-up has concluded.

Keywords
Neoadjuvant Treatment, Nivolumab
Medical subject headings
Pancoast Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Paraplatin

    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.

  • PaclitaxelDrug

    Also called Taxol

    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.

  • NivolumabDrug

    Also called Opdivo

    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.

Study groups in NCT05684276
Study groupRoleWhat they receive
Experimental: Neodjuvant treatment + Adjuvant maintenance treatmentExperimentalNeodjuvant 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
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimate progression-free survival (PFS)

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

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

Secondary outcomes (3)

  1. Overall survival

    The length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.

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

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

    It will be measured by the incidence of AE, SAE, immune-related AEs, deaths, and laboratory abnormalities. Adverse events will be graded according to CTCAE v5.0

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

  3. Complete resection (R0) rate

    Defined as the time between the date of randomization and the date of death

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2023
  2. Study start12 May 2023
  3. Primary completion1 Mar 2028 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05684276
Sponsor's protocol ID
GECP 22/02_DUMAS
Other IDs
2022-003717-11
Acronym
DUMAS
Status last verified
Apr 2026
First submitted
5 Jan 2023
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Paclitaxel and Nivolumab in people with NSCLC and Pancoast Tumor, run by Fundación GECP at 29 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimate progression-free survival (PFS) (time frame: From the date randomization until the date of last follow up, assessed up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05684276.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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