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Non Small Cell Lung CancerPhase 2NCT03081689

Neo-Adjuvant Immunotherapy With Nivolumab for Non Small Cell Lung Cancer Patients

A Phase 2 study testing Nivolumab 360 mg, Paclitaxel 200mg/m2 and Carboplatin AUC 6 in people with Non Small Cell Lung Cancer, run by Spanish Lung Cancer Group at 24 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase II, single-arm, open-label multicenter study that assesses feasibility, safety and efficacy of combined neoadjuvant chemotherapy and immunotherapy with Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Nivolumab 360 mg, Paclitaxel 200mg/m2 and Carboplatin AUC 6
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
24 sitesSpain
Study dates
15 Apr 2017to 18 Oct 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subjects eligible for the study are those with histologically- or cytologically- documented NSCLC who present stage IIIA disease. Locally advanced patients who present stage IIIA by the previous version can be included if are considered potencially resectable. In case of N2 disease suspicion, pathological assessment by EBUS, mediastinoscopy or thoracotomy has to be carried out for N2 confirmation.
  • Tumor should be considered resectable before study entry
  • Performance Status of 0 or 1
  • Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to registration/inclusion i. WBC ≥ 2000/μL ii. Neutrophils ≥ 1500/μL iii. Platelets ≥ 100 x103/μL iv. Hemoglobin > 9.0 g/dL v. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula below): a. Female CrCl = (140 - age in years) x weight in kg x 0.85
  • 1. 72 x serum creatinine in mg/dL
  • Male CrCl = (140 - age in years) x weight in kg x 1.00
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  • 72 x serum creatinine in mg/dL vi. AST/ALT ≤ 3 x ULN vii. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) viii. INR/APTT within normal limits
  • 5. The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters
  • 6. All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and nacional guidelines, including the Declaration of Helsinki prior to any trial-related intervention.
  • 7. Patients aged > 18 years
  • 8. Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception.
  • 9. Women must not be breastfeeding
  • 10. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year.

Who cannot join

  • All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene.
  • Patients with active, known or suspected autoimmune disease.
  • Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
  • Patients with a history of interstitial lung disease cannot be included if they have sympthomatic ILD (Grade 3-4)
  • Patients with other active malignancy requiring concurrent intervention
  • 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
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  • Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study
  • Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody,
  • Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody)
  • Patients with known history of testing positive for human immunodeficiency virus (HIV)
  • Patients with history of allergy to study drug components excipients

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Spain24 sites

  • Complejo hospitalario de la coruña

    A Coruña, Coruña, 15006

  • Hospital General de Alicante

    Alicante, 03010

  • Hospital Universitari Quirón Dexeus

    Barcelona, 08028

  • Hospital Universitari Vall Hebrón

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041

  • H. Duran i Reynals-ICO

    Barcelona, 08907

  • Hospital de Cruces

    Bilbao, Vizcaya, 48903

  • Hospital Reina Sofía

    Córdoba, Córdoba, 14004

  • Hospital Insular de Gran Canaria

    Las Palmas de Gran Canaria, Gran Canaria, 35016

  • H. de la Princesa

    Madrid, 28006

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Fundación Jiménez Díaz

    Madrid, 28040

  • H. La Paz

    Madrid

  • Hospital Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Son Espases

    Palma de Mallorca, 07010

  • Clínica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Hospital Clinico de Salamanca

    Salamanca, 37007

  • Hospital Virgen de La Macrena

    Seville, 41009

  • Hospital Virgen Del Rocío

    Seville, 41013

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • H. Gen. Univ. Valencia

    Valencia

  • Hospital La Fe

    Valencia

  • Complejo Hospitalario de Vigo

    Vigo, Pontevedra, 36212

Other trials in Spain

About this study

Official title: Neo - Adjuvant Chemo / Immunotherapy for the Treatment of Resectable Stage IIIA Non Small Cell Lung Cancer (NSCLC): A Phase II Multicenter Exploratory Study

Phase II, single-arm, open-label multicenter study that assesses feasibility, safety and efficacy of combined neoadjuvant chemotherapy and immunotherapy with Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months.

Read the detailed description

Phase II, single-arm, open-label multicenter study that assesses feasibility, safety and efficacy of combined neoadjuvant chemotherapy and immunotherapy with Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months.

Three cycles of neoadjuvant chemotherapy in combination with nivolumab will be administered.

After completion of neoadjuvant therapy (3 cycles) and before surgery, a tumor assessment will be done. Patients have to leave the study if there is evidence of progression. Patients with in-stable disease or partial response may be considered for surgery.

The report imaging response vs pathological response rate will be evaluated.

Patients eligible for the trial are those with a histological diagnosis or cytologically proven operable and resectable non-small-cell lung cancer. The total number of patients to be included will be 46 from 23 participating sites in Spain.

Accrual period of 1.5 years or until the inclusion of the last patient necessary to achieve the sample set in the protocol of 46 patients. After that all patients will be treated for 1 year with adjuvant immunotherapy and they will be followed during 3 years after adjuvant treatment.

Being tested
Nivolumab 360 mg, Paclitaxel 200mg/m2, Carboplatin AUC 6
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Nivolumab 360 mgDrug

    Also called OPDIVO

    Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months

  • Paclitaxel 200mg/m2Drug

    Also called Paclitaxel

    Paclitaxel 200mg/m2 IV Q3W

  • Carboplatin AUC 6Drug

    Also called Carboplatin

    Carboplatin AUC 6 IV Q3W

Study groups in NCT03081689
Study groupRoleWhat they receive
Arm 1ExperimentalNivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Receives: Drug: Nivolumab 360 mg; Drug: Paclitaxel 200mg/m2; Drug: Carboplatin AUC 6

What is being measured

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

  1. Progression Free Survival

    The progression free survival is the percentage of the patients without disease progression

    Measured: at 24 months from the first dose of neoadjuvant treatment

Secondary outcomes (1)

  1. Overall Survival

    Percentage of patients are still alive

    Measured: at 3 years from the first dose of neoadjuvant treatment

Timeline

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

  1. First posted16 Mar 2017
  2. Study start15 Apr 2017
  3. Primary completion15 Sep 2023
  4. Study completion18 Oct 2023

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
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03081689
Sponsor's protocol ID
GECP 16/03_NADIM
Status last verified
Nov 2024
First submitted
10 Mar 2017
Last updated
4 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Provencio M, Serna-Blasco R, Nadal E, Insa A, Garcia-Campelo MR, Casal Rubio J, Domine M, Majem M, Rodriguez-Abreu D, Martinez-Marti A, De Castro Carpeno J, Cobo M, Lopez Vivanco G, Del Barco E, Bernabe Caro R, Vinolas N, Barneto Aranda I, Viteri S, Pereira E, Royuela A, Calvo V, Martin-Lopez J, Garcia-Garcia F, Casarrubios M, Franco F, Sanchez-Herrero E, Massuti B, Cruz-Bermudez A, Romero A. Overall Survival and Biomarker Analysis of Neoadjuvant Nivolumab Plus Chemotherapy in Operable Stage IIIA Non-Small-Cell Lung Cancer (NADIM phase II trial). J Clin Oncol. 2022 Sep 1;40(25):2924-2933. doi: 10.1200/JCO.21.02660. Epub 2022 May 16.

    PubMed 35576508

  • Provencio M, Nadal E, Insa A, Garcia-Campelo MR, Casal-Rubio J, Domine M, Majem M, Rodriguez-Abreu D, Martinez-Marti A, De Castro Carpeno J, Cobo M, Lopez Vivanco G, Del Barco E, Bernabe Caro R, Vinolas N, Barneto Aranda I, Viteri S, Pereira E, Royuela A, Casarrubios M, Salas Anton C, Parra ER, Wistuba I, Calvo V, Laza-Briviesca R, Romero A, Massuti B, Cruz-Bermudez A. Neoadjuvant chemotherapy and nivolumab in resectable non-small-cell lung cancer (NADIM): an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2020 Nov;21(11):1413-1422. doi: 10.1016/S1470-2045(20)30453-8. Epub 2020 Sep 24.

    PubMed 32979984

  • Provencio M, Nadal E, Insa A, Garcia Campelo R, Casal J, Domine M, Massuti B, Majem M, Rodriguez-Abreu D, Martinez-Marti A, de Castro J, Gomez de Antonio D, Macia I, Figueroa S, Fernandez Vago L, Calvo V, Palmero R, Sierra-Rodero B, Martinez-Toledo C, Molina-Alejandre M, Serna-Blasco R, Romero A, Cruz-Bermudez A. Perioperative chemotherapy and nivolumab in non-small-cell lung cancer (NADIM): 5-year clinical outcomes from a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2024 Nov;25(11):1453-1464. doi: 10.1016/S1470-2045(24)00498-4. Epub 2024 Oct 14.

    PubMed 39419061

  • Sierra-Rodero B, Cruz-Bermudez A, Nadal E, Garitaonaindia Y, Insa A, Mosquera J, Casal-Rubio J, Domine M, Majem M, Rodriguez-Abreu D, Martinez-Marti A, De Castro Carpeno J, Cobo M, Lopez Vivanco G, Del Barco E, Bernabe Caro R, Vinolas N, Barneto Aranda I, Viteri S, Massuti B, Laza-Briviesca R, Casarrubios M, Garcia-Grande A, Romero A, Franco F, Provencio M. Clinical and molecular parameters associated to pneumonitis development in non-small-cell lung cancer patients receiving chemoimmunotherapy from NADIM trial. J Immunother Cancer. 2021 Aug;9(8):e002804. doi: 10.1136/jitc-2021-002804.

    PubMed 34446577

  • Casarrubios M, Cruz-Bermudez A, Nadal E, Insa A, Garcia Campelo MDR, Lazaro M, Domine M, Majem M, Rodriguez-Abreu D, Martinez-Marti A, de Castro-Carpeno J, Cobo M, Lopez-Vivanco G, Del Barco E, Bernabe Caro R, Vinolas N, Barneto Aranda I, Viteri S, Massuti B, Barquin M, Laza-Briviesca R, Sierra-Rodero B, Parra ER, Sanchez-Espiridion B, Rocha P, Kadara H, Wistuba II, Romero A, Calvo V, Provencio M. Pretreatment Tissue TCR Repertoire Evenness Is Associated with Complete Pathologic Response in Patients with NSCLC Receiving Neoadjuvant Chemoimmunotherapy. Clin Cancer Res. 2021 Nov 1;27(21):5878-5890. doi: 10.1158/1078-0432.CCR-21-1200. Epub 2021 Aug 10.

    PubMed 34376534

  • Laza-Briviesca R, Cruz-Bermudez A, Nadal E, Insa A, Garcia-Campelo MDR, Huidobro G, Domine M, Majem M, Rodriguez-Abreu D, Martinez-Marti A, De Castro Carpeno J, Cobo M, Lopez Vivanco G, Del Barco E, Bernabe Caro R, Vinolas N, Barneto Aranda I, Viteri S, Massuti B, Casarrubios M, Sierra-Rodero B, Tarin C, Garcia-Grande A, Haymaker C, Wistuba II, Romero A, Franco F, Provencio M. Blood biomarkers associated to complete pathological response on NSCLC patients treated with neoadjuvant chemoimmunotherapy included in NADIM clinical trial. Clin Transl Med. 2021 Jul;11(7):e491. doi: 10.1002/ctm2.491.

    PubMed 34323406

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab 360 mg, Paclitaxel 200mg/m2 and Carboplatin AUC 6 in people with Non Small Cell Lung Cancer, run by Spanish Lung Cancer Group at 24 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 11 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: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 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?

Yes. Results are posted in the registry (first posted 4 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression Free Survival (time frame: at 24 months from the first dose of neoadjuvant treatment). 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 NCT03081689, which also lists 6 linked publications.

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 4 Dec 2024.

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