聚焦印度：肺癌试验准备情况

India in Focus: Lung Cancer RAINA SINGH PAPLIKAR,Head, Marketing and Corporate Communications, R&D Solutions, IQVIA APACCECILIA WONG, Marketing Manager, R&D Solutions, IQVIA APAC Table of contents Executive summary1Theglobal lung cancer landscape2India’slung cancer landscape:Gaps and growth potential5Regulatoryevolution enabling faster trials6Operationalreadiness and site infrastructure7Voices from India’sclinical research community9The IQVIAadvantage10Keytakeaway10Conclusion11Disclaimer11Acknowledgement12References13About the authors14 Executive summary Lung cancer remains theleading cause of cancermortality worldwide, with nearly2.5 million newcases and 1.8 million deaths recorded in 2022. In These advances are complemented by the leadershipof India’s clinical researchers and institutions, includingthe Tata Memorial-led National Cancer Grid, which These figures highlight both theglobal urgency and the nationalburden that demand faster The introduction of theNew Drugs and ClinicalTrials Rules (NDCTR) 2019has brought newpredictability to approval timelines. Investments ininfrastructure have created a network of more than These developments frame three themes thatguide this whitepaper: the global urgency of lungcancer research, India’s opportunity to address itsgrowing burden through clinical trials, and IQVIA’s “Lung cancer was the mostfrequently diagnosed cancer in2022, responsible for almost Theglobal lung cancer Globally, lung cancer continues to dominate theoncology landscape both in scale and impact. Itaccounted for almost2.5 million new cases and — Antonio Rossi The burden is shaped primarily by two categories: NSCLC and SCLC. NSCLC represents the majority of cases andhas undergone significant transformation in recent years, shifting from reliance on chemotherapy to targetedtherapies, immunotherapy, and biomarker-driven regimens. Advances in genomic profiling now make it possible SCLCpresents a more complex challenge. Progress has historically been limited, but recent developments suchas chemo-immunotherapy combinations and novel T-cell engaging agents are beginning to expand treatment Source: 1. NCCN Guideline SCLC_ V4.2025 The global research pipeline reflects this intensity. By mid-2025, more than 1,600 trials were ongoing inNSCLC and nearly 1,900 in SCLC across multiple geographies. Most are concentrated in advanced disease andfocus on new immunotherapy combinations, targeted therapies, and antibody-drug conjugates. This wave of For healthcare innovators, these global trends set the context for why regions with large patient populationsand growing research infrastructure, such as India, are increasingly critical to the future India’slung cancer landscape: Gaps andgrowth potential India faces a substantial cancer burden, with close to1.5 million new diagnoses and around one million deathsin 2022.Lung cancer ranks among the country’s top five cancers, with an estimated80,000 new cases and 75,000 Despite this scale, the trial landscape in India remains limited compared to global activity. Most cancer trials arePhase III studies, with relatively few Phase I and II initiatives. This preference for later-stage research reduces The treatment landscape for NSCLC in India continuesto evolve, with increasing emphasis on histology,stage at diagnosis, and biomolecular profiling.Comprehensive testing at first diagnosis, particularly in “NDCTR 2019 has brought realpredictability to trial approvals.Most of the approvals we see are — Shwetha PradhanHead, Clinical Operations India, IQVIA Progress in SCLC has been slower. Improvements inboth limited and extensive disease have only emergedin the last few years, largely through the integration The frequency of Subject Expert Committee (SEC)meetings for oncology has been raised to at least twiceper month, and specialized committees are being Geographic disparities further illustrate the unevenlandscape. Large urban research centers are betterequipped with trial infrastructure and diagnostics, Capacity-building initiatives are also strengtheningthe ecosystem. The National Program for Preventionand Control of Cancer, Diabetes, CardiovascularDiseases and Stroke (NPCDCS) has improved earlydetection, screening, and treatment infrastructure,with 770 district clinics, 19 state cancer institutes, and India’s lung cancer landscape reveals both pressingchallenges and clear potential. Broader genomictesting, more early-phase and SCLC research, and Regulatoryevolution Together, these reforms have reduced approvaltimelines, raised oversight quality, and expandedIndia’s ability to support complex oncology trials. For A key driver of India’s readiness for oncology researchhas been the transformation of its regulatoryenvironment. The introduction of NDCTR 2019 marked This greater predictability has created a more friendlyenvironment for drug developers and increased Today, IQVIA maintains a database of more than 60mapped lung cancer trial-ready trial