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Clinical Studies

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Clinical Studies (Principal Investigator):

 A randomized, double-blind, placebo-controlled, phase III study evaluating the  efficacy and safety of pembrolizumab plus platinum-based chemotherapy with  or without canakinumab as first line therapy for locally advanced or metastatic  non-squamous and squamous non-small cell lung cancer subjects 

(CANOPY-1) 

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-center  Study of Durvalumab Monotherapy or in Combination with Bevacizumab as  Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High  Risk of Recurrence After Curative Hepatic Resection or Ablation 

(EMERALD-2)

 A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study  of Transarterial Chemoembolization (TACE) in Combination with either  Durvalumab Monotherapy or Durvalumab plus Bevacizumab Therapy in  Patients with Locoregional Hepatocellular Carcinoma (EMERALD-1))

A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination  Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatmet in  Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell  Lung Cancer (MARIPOSA) 

EPIK-B3: A Phase III, multicenter, randomized, double-blind, 

placebo-controlled study to assess the efficacy and safety of alpelisib  (BYL719) in combination with nab-paclitaxel in patients with advanced triple  negative breast cancer with either phosphoinositide-3-kinase catalytic subunit  alpha (PIK3CA) mutation or phosphatase and tensin homolog protein (PTEN)  loss without PIK3CA mutation 

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based  Chemotherapy Compared With Platinum-Based Chemotherapy in Patients  With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced  or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure  (MARIPOSA-2) 

A Multicountry, Multicentre, Noninterventional, Retrospective Study to  Describe the Real-world Management Outcomes in Patients with  Unresectable Hepatocellular Carcinoma. (OREIOS)

A descriptive study of PIK3CA mutations in patients with HR+/Her2-advanced  breast cancer (PIK3CA Registry Study)

A Prospective, Multicenter, Non-Interventional, Observational, Real-World  Study to Evaluate the Safety, Adherence to Therapy, and Effectiveness of a  T-DM1 Antibody-Drug Conjugate Biosimilar in Indian Patients with HER2-Positive Early Breast Cancer

Clinical Studies (Co Investigator):

A phase III, multicenter, randomized, double blind, placebo controlled study  evaluating the efficacy and safety of canakinumab versus placebo as adjuvant  therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm

N2) completely resected (R0) non-small cell lung cancer (NSCLC) (CANOPY  A) 

A Phase III, Double-blind, Placebo-controlled, Multi-center International Study  of Neoadjuvant / Adjuvant Durvalumab for the Treatment of Patients with  Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)

A Phase III, Open-label, Randomized Study of Osimertinib with or without  Platinum Plus Pemetrexed Chemotherapy, as First-line Treatment in Patients  with Epidermal Growth Factor Receptor (EGFR) Mutation- Positive, Locally  Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA2).

SINGLE ARM STUDY TO EVALUATE THE SAFETY OF DACOMITINIB FOR  THE FIRST LINE TREATMENT OF PARTICIPANTS IN INDIA WITH  METASTATIC NON SMALL CELL LUNG CANCER WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) ACTIVATING MUTATIONS 

 “SINGLE-ARM STUDY TO EVALUATE THE SAFETY OF LORLATINIB IN  ALK INHIBITOR-TREATED UNRESECTABLE ADVANCED AND/OR  RECURRENT ALK-POSITIVE NON-SMALL CELL LUNG CANCER PARTICIPANTS IN INDIA”

“A Phase III Double-blind Randomized Study Assessing the Efficacy and  Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line  Treatment for Patients with Histologically Confirmed, Locally Advanced  (Inoperable) or Metastatic Triple-Negative Breast Cancer(TNBC) (Capitello290)”

 “A Phase III Randomized, Double-Blind, Placebo-Controlled, Multi-Regional,  International Study of Durvalumab in Combination with Gemcitabine plus  Cisplatin versus Placebo in Combination with Gemcitabine plus Cisplatin for  Patients with First-Line Advanced Biliary Tract Cancers (TOPAZ-1)”

 A prospective , Multicentre, Phase -IV Clinical Trial of Olaparib in the Indian  Patients with Platinum Sensitive Relapsed Ovarian Cancer who are in  Complete or Partial Response Following Platinum Based Chemotherapy and  Metastatic Breast Cancer with Germline BRCA 1/2 Mutation (Soli Study) 

A Randomized, Open-label Phase 3 Study of Combination Amivantamab and  Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in  Patients with EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (PAPILLON)

 A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an  ORAL SERD) plus Palbociclib versus Anastrozole plus Palbociclib for the  Treatment of Patients with Estrogen Receptor-Positive, HER2-Negative  Advanced Breast Cancer Who Have Not Received Any Systemic Treatment  for Advanced Disease (SERENA-4) 

A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab  Deruxtecan (T DXd) Versus Investigator’s Choice Chemotherapy in HER2 low, Hormone Receptor Positive Breast Cancer Patients whose Disease has  Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY  Breast06)

A Randomised, Double-blind, Placebo-controlled, Phase III Study of Olaparib  Maintenance Monotherapy in Patients with BRCA Wild Type Advanced (FIGO  Stage III-IV) High Grade Serous or Endometriod Ovarian Cancer Following  Response to Standard First-line Platinum-based Chemotherapy (MONO-OLA)

“A Phase III, Randomised, Double blind, Placebo controlled, Multicentre,  International Study of Durvalumab plus Domvanalimab (AB154) in Participants with Locally Advanced (Stage III), Unresectable Non-Small Cell  Lung Cancer Whose Disease has not Progressed Following Definitive  Platinum based Concurrent Chemoradiation Therapy (PACIFIC-8)

Prevalence of BRCA1 and BRCA2 Mutation Among Indian Breast Cancer  Patients: A Multicenter Cross-Sectional Study 

A prospective, multicenter, Phase-IV clinical trial to assess safety of  Durvalumab in Indian adult patients with locally advanced, unresectable  non-small cell lung cancer (NSCLC) and urothelial cancer. 

A Phase IV ,Multicenter,Open Label,single Arm study of Paertuzumab(In  combination of Trastuzumab with Docetaxel)In 1st line treatment of Indian  Patients with Her 2 Positive Advanced(Metasatic or Locally recurrent)Breast  Cancer. 

A Phase III, randomized study of Oral LDK378 versus standard chemotherapy  in previously untreated adult patients with ALK rearranged(ALK Positive),IIIB  or IV,non squamous non small cell lung cancer.

 An Open Label, Single Arm, Multicenter, Safety Study of Atezolizumab in  Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the  Urinary Tract

An Open Label , Randomized, Multicenter, phase 2, Safety Study and  efficacy study of Capmatinib (INC 280) plus Pembrolizumab versus  Pembrolizumab alone in locally Advanced Or Metastatic non small cell lung  cancer.

A Multicenter Phase 4, Open-label, single-arm, Safety and Efficacy Study of  Enzalutamide in Indian patients with Progressive Metastatic 

Castration-Resistant Prostate Cancer (9785-CL-0413) 

RANDOMIZED, OPEN LABEL, MULTICENTER, PHASE III STUDY OF  ENTRECTINIB VERSUS CRIZOTINIB IN PATIENTS WITH LOCALLY  ADVANCED OR METASTATIC NON SMALL CELL LUNG CANCER HARBOURING ROS1 GENE REARRANGEMENTS WITH AND WITHOUT  CENTRAL NERVOUS SYSTEM METASTASES.