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JOURNAL ONKOLOGIE – STUDIE

A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

Rekrutierend

NCT-Nummer:
NCT04025879

Studienbeginn:
September 2019

Letztes Update:
30.10.2020

Wirkstoff:
Nivolumab, Carboplatin, Cisplatin, Paclitaxel, Pemetrexed, Placebo, Docetaxel

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Bristol-Myers Squibb

Collaborator:
-

Studienleiter

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Kontakt

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Kontakt:
Phone: please email:
E-Mail: Clinical.Trials@bms.com» Kontaktdaten anzeigen
First line of the email MUST contain NCT# and Site #.

Studienlocations (3 von 122)

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Studien-Informationen

Brief Summary:

The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant)

immunotherapy will prolong event free survival in participants with early stage non-small

cell lung cancer.

Ein-/Ausschlusskriterien

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please

visit www.BMSStudyConnect.com

Inclusion Criteria:

- Participants with suspected or histologically confirmed Stage IIA (> 4 cm) to IIIB

(T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered

resectable

- No brain metastasis

- Treatment-naive for NSCLC (no prior systemic anti-cancer treatment)

- Ability to provide surgical or biopsy tumor tissue for biomarkers

- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

Exclusion Criteria:

- Participants with an active, known or suspected autoimmune disease

- Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency

virus (HIV)

- Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents,

or radiotherapy for NSCLC

- Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody,

or any other antibody or drug specifically targeting T-cell co-stimulation or

checkpoint pathways

Other protocol-defined inclusion/exclusion criteria apply

Studien-Rationale

Primary outcome:

1. Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR) (Time Frame - 5 Years from randomization)



Secondary outcome:

1. Overall Survival (OS) (Time Frame - Up to 5 years from randomization)

2. Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR) (Time Frame - At the time of surgery, between week 12 to week 18)

3. Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review (Time Frame - Up to 8 weeks following completion of neoadjuvant surgery, approximately study week 22)

4. Incidence of Serious Adverse Events (SAEs) (Time Frame - Up to 80 weeks)

5. Incidence of Adverse Events (AEs) (Time Frame - Up to 80 weeks)

Studien-Arme

  • Experimental: Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
  • Placebo Comparator: Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.

Geprüfte Regime

  • Nivolumab (Opdivo, BMS936558):
    Specified dose on specified days
  • Carboplatin:
    Specified dose on specified days
  • Cisplatin:
    Specified dose on specified days
  • Paclitaxel:
    Specified dose on specified days
  • Pemetrexed:
    Specified dose on specified days
  • Placebo:
    Specified dose on specified days
  • Docetaxel:
    Specified dose on specified days

Quelle: ClinicalTrials.gov


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