Atezolizumab in Advanced Non-small Cell Lung Cancer With Rare Histologies (CHANCE Trial)

NCT03976518 | Completed Phase 2 DMC

• 1 other identifier: GOIRC-02-2018
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 10

Brief Summary

This study is aimed to explore the antitumor activity and the safety profile of atezolizumab in pretreated advanced NSCLC patients with rare histological subtypes.

Conditions

Non-Small Cell Lung Cancer

Keywords

Advanced Non-Small Cell Lung Cancer; NSCLC Rare Histological Subtypes

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR)

  Proportion of patients presenting Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) based on the Investigator's assessment according to standard RECIST criteria v.1.1.

  From the start of treatment (baseline) to the progression of disease (PD) or trial discontinuation whichever occurs first, assessed up to 24 months.

Secondary Outcomes (5)

• Treatment Safety based on Adverse Events Frequency and Safety

  From the treatment start to 90 days after the administration of the last treatment dose. The outcome is assessed up to a maximum of 27 months.

• Objective Response Rate (ORR)

  From the start of treatment (baseline) to the progression or stability of disease assessed up to 24 months.

• Overall Survival (OS)

  From the date of enrollment to the date of death from any cause. The survival follow-up will continue until 6 months after the last subject receives the last dose of atezolizumab

• Time To Progression (Time To Progression)

  From the date of enrollment to the date of objective tumor progression assessed up to 24 months.

• Progression Free Survival (PFS)

  From the date of enrollment to the date of objective disease progression or death assessed up to 24 months.

Other Outcomes (9)

• Duration of Response (DoR)

  From the time of documentation of tumor response to the time of disease progression assessed up to 24 months after baseline

• Time to Response

  The occurrence of a response will be assessed from baseline up to 24 months

• Tumor shrinkage in target lesions

  Up to 36 months from the treatment start

Study Arms (1)

ATEZOLIZUMAB

EXPERIMENTAL

Atezolizumab will be administered at a flat dose of 1200 mg by intravenous route. Atezolizumab will be delivered in 250-mL 0.9% NaCl (sodium chloride) intravenous (IV) infusion bags. The administration will be repeated every 3 weeks (21 \[± 3\] days). The initial dose will be delivered over 60 (± 15) minutes. In case the first infusion is tolerated without any infusion-associated AEs the second infusion may be delivered over 30 (± 10) minutes. If the second 30 minutes infusion is well tolerated all the subsequent infusions may be administered over 30 (± 10) minutes. The treatment will be continued until disease progression, intolerable toxicity, patient refusal or Investigator's decision or any criterion for withdrawal from the trial or trial drug is fulfilled.

Drug: Atezolizumab

Interventions

Atezolizumab DRUG

Atezolizumab will be administered on Day 1 every 21 days (+/- 3 days).

ATEZOLIZUMAB

Eligibility Criteria

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

You may qualify if:

• Locally advanced, relapsed or metastatic non-small cell lung cancer (NSCLC) - stage IIIB/IV according to 7th International Association for the Study of Lung Cancer (IASLC) classification
• Histologically confirmed diagnosis of non-small cell lung cancer (NSCLC) with rare histological subtype, according to World Health Organization (WHO) 2015 classification. Histologic subtype variants to be enrolled into the study include: colloid adenocarcinoma (or adenocarcinoma with colloid features); fetal adenocarcinoma (or adenocarcinoma with fetal features); large cell carcinoma (LCC); sarcomatoid carcinoma (pleomorphic, spindle cell, and/or giant cell carcinoma, carcinosarcoma, pulmonary blastoma); salivary gland-type tumors (mucoepidermoid carcinoma, adenoid cystic carcinoma, epithelial-myoepithelial carcinoma), other and unclassified carcinomas (lymphoepithelioma-like carcinoma, NUT-nuclear protein in testis-carcinoma)
• Availability of tumor sample (material obtained from core-biopsy or surgical specimen) for central pathology revision is mandatory
• Availability of a formalin-fixed, paraffin-embedded (FFPE) tumor block or 7-10 unstained tumor slides suitable for PD-L1 expression assessment is mandatory. The assessment of PD-L1 expression will be performed by using both SP-142 and SP-263 antibody assays. The collection of tumor sample should be performed before patients are enrolled into the study
• Male and female and ≥ 18 years of age
• Life expectancy ≥ 12 weeks
• Progressive disease after or during at least one previous standard chemotherapy line
• Measurable disease per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1); clear radiological evidence of disease progression after previous treatment has to be documented
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2
• Patients with treated brain metastases with stable lesions for at least 2 weeks either off steroids or on a stable dose or decreasing dose of steroids (≤ 10 mg prednisone or equivalent daily) will be enrolled. Radiotherapy must have been completed a minimum of 14 days prior to registration, and patients must have recovered from adverse events (AEs) related to radiotherapy to \< grade 1 (except alopecia)
• For Females: must be postmenopausal for at least 1 year before the screening visit, or are surgically sterile or not sexually active. Women of childbearing potential (WOCBP) must use 2 effective methods of contraception with a failure rate of less than 1% per year, during the entire study treatment period and for a period of 5 months after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. WOCBP must have a negative serum pregnancy test during the screening period
• Adequate haematological function defined by white blood cell (WBC) count ≥2,500/mm3 with absolute neutrophil count (ANC) ≥1,500/mm3, platelet count - Adequate hepatic function defined by a total bilirubin ≤ 1.5 x the upper limit of normal (ULN) range (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL), serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 if liver function test elevations are due to liver metastases)
• Adequate renal function defined by a serum creatinine ≤ 1.5 x ULN or an estimated creatinine clearance of ≥ 30 mL/minute for patients with creatinine levels above institutional limits (if using the Cockcroft-Gault formula)

You may not qualify if:

• Recovered (i.e., ≤ Grade 1 toxicity) from effects of prior anticancer therapy, except alopecia
• Ability to comply with protocol requirements
• The patient is able to provide written informed consent. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care.
• Prior treatment with Atezolizumab or any other immunotherapy agents (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways)
• Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
• Concurrent anticancer treatment, immune therapy, or cytokine therapy, except for erythropoietin
• Major surgery for any reason within 4 weeks (or 2 weeks for minor surgery) from registration and/or if the subject has not fully recovery from the surgery within 4 weeks of registration
• Subjects receiving immunosuppressive agents such as steroids for any reason should be tapered off these drugs before initiation of the trial treatment. Corticosteroid therapy with a dose ≤ 10 mg prednisone or equivalent will be allowed. Note:
• Subjects receiving bisphosphonates or denosumab are eligible provided treatment was initiated at least 14 days before first dose of trial treatment
• Previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon is acceptable as long as it is anticipated that the administration of steroids will be completed in 14 days, or that the daily dose after 14 days will be ≤10 mg per day of equivalent prednisone
• Persisting toxicity related to prior therapy of grade \>1 according to National Cancer Institute - Common Terminology Criteria Adverse Event (NCI-CTCAE) v. 4.03
• Known severe hypersensitivity reactions to chimeric or monoclonal antibodies, fusion proteins (grade ≥3 NCI-CTCAE v. 4.03)
• Patients with untreated, symptomatic and/or progressive brain metastases, or with carcinomatous meningitis. Subjects with brain metastases are eligible if metastases have been treated and there is no clinical evidence of progression for \[lowest minimum is 2 weeks or more\] after treatment is complete and within 28 days prior to the first dose of atezolizumab administration. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of 10 mg daily prednisone (or equivalent)
• History of autoimmune disease, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis. Subjects with diabetes mellitus type I, hypothyroidism only requiring hormone replacement or controlled hyperthyroidism, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol. Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of registration will be not eligible. Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg or 10 mg equivalent prednisone per day. Topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption) are permitted
• Any medical condition requiring a systemic corticosteroid treatment at doses \>10 mg prednisone per day or equivalent or other immunosuppressive therapies

Sponsors & Collaborators

• Gruppo Oncologico Italiano di Ricerca Clinica: lead
• AOU S.Orsola Malpighi-Unit of Oncologic Molecular and Transplantations Pathology: collaborator
• Istituto Toscano Tumori: collaborator
• YGHEA, CRO Division of Ecol Studio spa: collaborator
• Iqvia Pty Ltd: collaborator
• AOU S. Orsola Malpighi - Clinical Trial Office: collaborator
• Silvano Chiapparoli Logistica SpA: collaborator
• Roche SpA: collaborator

Study Sites (10)

UO Oncologia Polmonare - AOU S. Luigi Gonzaga

Orbassano, Torino, 10043, Italy

Location

UO di Oncologia Medica - Azienda Ospedaliero-Universitaria S. Orsola Malpighi

Bologna, 40138, Italy

Location

Dipartimento di Oncologia Medica - Azienda Ospedaliera S.Croce e Carle Cuneo - Ospedale Carle

Cuneo, 12100, Italy

Location

S.S. di Oncologia Medica toraco-polmonare - Fondazione IRCCS - Istituto Nazionale Tumori

Milan, 20133, Italy

Location

U.O.C Pneumologia ad Indirizzo Oncologico -AORN Ospedali dei Colli Monaldi-Cotugno-CTO

Napoli, 80131, Italy

Location

UOC di Oncologia Medica 2 - IOV Istituto Oncologico Veneto

Padua, 35128, Italy

Location

UOC di Oncologia Medica - Azienda Ospedaliero Universitaria di Parma

Parma, 43126, Italy

Location

US di Oncologia Medica - A.O. di Perugia

Perugia, 06129, Italy

Location

S.C. di Oncologia Medica - IFO - Istituto Regina Elena

Roma, 00144, Italy

Location

UOC di Oncologia Medica - Azienda Sanitaria Universitaria Integrata di Udine

Udine, 33100, Italy

Location

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Andrea Ardizzoni, MD

  Dept Oncology-Haematology - S.Orsola-Malpighi Hospital - Bologna - Italy

  PRINCIPAL INVESTIGATOR

• Francesco Gelsomino, MD

  Dept Oncology-Haematology - S.Orsola-Malpighi Hospital - Bologna - Italy

  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

Model Details: Single-arm, open label clinical trial

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 6, 2019
• Study Start: May 7, 2019
• Primary Completion: February 12, 2024
• Study Completion: February 12, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

IT (10)