PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Thu, 23 Sep 2021 19:22:35 GMT) CTRI Number CTRI/2017/11/010690 [Registered on: 29/11/2017] - Trial Registered Prospectively Last Modified On 26/04/2021 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study A clinical trial to study the efficacy and safety of Atezolizumab compared with standard Chemotherapy in Non-Small Cell Lung Cancer patients with poor performance status. Scientific Title of A Phase III, open-label, multicenter, randomized study to investigate the efficacy and safety of Study Atezolizumab compared with Chemotherapy in patients with treatment-naïve advanced or recurrent (Stage IIIb not amenable for multimodality treatment) or Metastatic (Stage IV) Non-small Cell Lung Cancer who are deemed unsuitable for platinum-containing Therapy Secondary IDs if Any Secondary ID Identifier Version 1.0 dated 13 Feb 2017 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Raju Titus Chacko Trial Coordinator (multi-center study) Designation Head & Professor - Medical Oncology Affiliation Address Department of Medical Oncology, Christian Medical College, Ida Scudder Road Vellore TAMIL NADU 632004 India Phone 914162283040 Fax 914163073410 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Raeesuddin Syed Query) Designation Medical Chapter Lead - Medical Affairs Affiliation Roche Products (India) Pvt. Ltd. Address 146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall, Lal Bahadur Shastri Marg, Ghatkopar, Mumbai - 400 086, Maharashtra, India Mumbai MAHARASHTRA 400051 India Phone 912233941414 Fax 912233941054 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Priyanka Bhattacharya Designation Lead– Clinical Operations Affiliation Roche Products (India) Pvt. Ltd. Address 146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall, Lal Bahadur Shastri Marg, Ghatkopar, Mumbai - 400 086, Maharashtra, India Mumbai page 1 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in MAHARASHTRA 400051 India Phone 022-33941476 Fax 912233941054 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > F. Hoffmann-La Roche Ltd. CH-4070, Basel, Switzerland Roche Products (India) Pvt. Ltd., 146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall, Lal Bahadur Shastri Marg, Ghatkopar, Mumbai - 400 086 Maharashtra, India Primary Sponsor Primary Sponsor Details Name F HoffmannLa Roche Ltd Address CH-4070, Basel, Switzerland Type of Sponsor Pharmaceutical industry-Global Details of Secondary Name Address Sponsor Roche Products India Pvt Ltd 146-B, 166 A, Unit No. 7, 8, 9, 8th Floor, R City Office, R City Mall, Lal Bahadur Shastri Marg, Ghatkopar, Mumbai - 400 086, Maharashtra, India India Countries of List of Countries Recruitment Algeria Belgium Brazil Bulgaria Canada China Colombia Czech Republic Denmark Germany India Ireland Italy Kazakhstan Luxembourg Mexico Peru Poland Portugal Romania Slovakia Spain Switzerland United Kingdom Viet Nam Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Randeep Singh Artemis Health Institute Sector 51, Gurgaon 9582449448 122001, Haryana, India page 2 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in Gurgaon [email protected] HARYANA Dr MVT Krishna Mohan Basavatarakam Indo Road No 10, Banjara 9866154503 American Cancer Hills, Hyderabad, Hospital & Research Telangana 500034, [email protected] Institute India Hyderabad ANDHRA PRADESH Dr Raju Titus Chacko Christian Medical Department of Medical 914162283040 College Oncology, Christian 914163073410 Medical College, Ida [email protected] Scudder Road, Vellore - .in 632 004, Tamil Nadu, India Vellore TAMIL NADU Dr Chetan Deshmukh Deenanath Mangeshkar Off Karve Road, 9850811449 Hospital and Research Erandwane, Pune Centre 411004, Maharashtra, chetandeshmukh.72@g India mail.com Pune MAHARASHTRA Dr Minish Mahendra Grant Medical 40, Sassoon Road, 9823133390 Jain Foundation Ruby Hall Pune 411001, Clinic Maharashtra, India [email protected] Pune om MAHARASHTRA Dr Ashish Kaushal HCG Cancer Center Sola Science City 9978297842 Road,Near Sola Bridge,S.G.Highway, [email protected] Ahmedabad-380060, Gujarat Ahmadabad GUJARAT Dr Rajnish Nagarkar HCG Manavata Cancer Behind Shivang Auto, 9823061929 Center Mumbai Naka,Nashik-4 02536661111 22002,Maharashtra,Indi drraj@manavatacancer a centre.com Nashik MAHARASHTRA Dr Manish Kumar Indraprastha Apollo Sarita Vihar, 9818736533 Singhal Hospitals Delhi-Mathura Road, New Delhi 110076, singhaloncocare@yaho India o.co.in New Delhi DELHI Dr Niraj Bhatt Kailash Cancer Hospital Muni Seva Ashram, 9925581480 And Research Center Goraj, Waghodia, Vadodara-391760, niraj.bhatt@greenashra Gujarat m.org Vadodara GUJARAT Dr Rajesh Mistry Kokilaben Dhirubhai Department of Medical 919320361267 Ambani Hospital & Oncology, Rao Saheb 912230970177 Medical Research Achutrao, Patwardhan [email protected] Institute Marg, Four Bunglows, Andheri West, Mumbai, Maharashtra 400053, India page 3 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in Mumbai MAHARASHTRA Dr Nitesh Rohatgi Max Super Speciality 2, Press Enclave Road, 9910003730 Hospital Saket, New Delhi 110017, India Nitesh.Rohatgi@maxhe New Delhi althcare.com DELHI Dr Sachin Almel P.D. Hinduja National OPD Building, 912224447006 Hospital & Medical Oncology Department, 912224440425 Research Centre Ground Floor, Veer [email protected] Savarkar Marg, Mahim m (W), Mumbai - 400016 Mumbai MAHARASHTRA Dr DC Doval Rajiv Gandhi Cancer Department of Medical 911147022428 Institute and Research Oncology, Sector 5, 911127051037 Center Rohini, New Delhi [email protected] 110085 North West DELHI Dr Hemant Malhotra SMS Medical College Birla Cancer Center, 911412573233 Hospital C-70, Ram Marg, Tilak 911412622899 Nagar, J.L.N Marg, drmalhotrahemant@gm Jaipur - 302 004, ail.com Rajasthan, India Jaipur RAJASTHAN Dr Moses Arunsingh S Tata Medical Center 14 Major Arterial Road 9007395797 (EW), Newtown, Rajarhat, Kolkata - moses.arunsingh@tmc 700160, West Bengal, kolkata.com India Kolkata WEST BENGAL Dr Prabhash Kumar Tata Memorial Centre Department of Medical 912224177214 Oncology, Dr. E.Borges 912224171734 Road, Parel, [email protected] Mumbai-400012, India. m Mumbai MAHARASHTRA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Review Approved 27/07/2018 No Board, Tata Medical Center, Kolkata Artemis Health Submittted/Under No Date Specified No Sciences Institutional Review Ethics Committee Ethics Committee Submittted/Under No Date Specified No Silver, Christian Review Medical College Ethics Committee-SMS Approved 02/07/2018 No Medical College, Jaipur HCG Multi Speciality Approved 21/12/2018 No Ethics Committee Institutional Ethics Approved 24/12/2018 No Commi page 4 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in Institutional Ethics Submittted/Under No Date Specified No Committee Review Institutional Ethics Submittted/Under No Date Specified No Committee - Clinical Review Studies Institutional Ethics Approved 26/04/2018 No Committee - P.D. Hinduja National Hospital & Medical Research Centre Institutional Ethics Submittted/Under No Date Specified No Committee, Review Basavatarakam Indo American Cancer Hospital & Research Institute Institutional Ethics Approved 15/10/2018 No Committee, Max Super Speciality Hospital Institutional Ethics Submittted/Under No Date Specified No Committee, Poona Review Medical Research Foundation Institutional Ethics Approved 23/11/2017 No Committee, Tata Memorial Centre Institutional Review Approved 18/12/2017 No Board, Rajiv Gandhi Cancer Institute & Research Center Institutional Scientific Approved 05/02/2018 No and Ethics Board Manavata Clinical Approved 29/11/2018 No Research Institute Ethics Committee Regulatory Clearance Status Date Status from DCGI Approved/Obtained 22/11/2017 Health Condition / Health Type Condition Problems Studied Patients Patients with locally advanced or metastatic Non Small Cell Lung Cancer with poor performance status Intervention / Type Name Details Comparator Agent Comparator Agent Vinorelbine [oral or intravenous] Both these drugs will be or Gemcitabine administered as per the product label Intervention Atezolizumab The dose of atezolizumab in this study will be 1200 mg administered by intravenous infusion on Day 1 of each 21-day cycle. Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 99.00 Year(s) Gender Both page 5 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in Details 1. Signed Informed Consent Form<br/> 2. Women or men aged ?18 years<br/> 3. Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC <br/> 4. No sensitizing epidermal growth factor receptor (EGFR) mutation (L858R or exon 19 deletions) or anaplastic lymphoma kinase (ALK) fusion oncogene detected <br/> 5. No prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC <br/> 6.Life expectancy ? 8 weeks <br/> 7.Deemed unsuitable for platinum-containing chemotherapy by the investigator