Solid Tumors & Immuno-Oncology
A comprehensive analysis of the oncology clinical trial landscape — from biomarker pre-screening infrastructure and adaptive design execution to community oncology integration and pipeline dynamics across checkpoint inhibitors, bispecifics, ADCs, and cell therapy.
The Oncology Trial Landscape in 2026
Oncology continues to dominate the global clinical trial landscape, accounting for approximately 35% of all active interventional studies. Within the Clinitiative network, oncology represents our largest therapeutic portfolio with 42 active studies across multiple solid tumor types and immuno-oncology indications. This volume reflects both the scale of unmet medical need and the extraordinary pace of therapeutic innovation in the field.
The distribution of active studies across our network reflects current pipeline dynamics: non-small cell lung cancer (NSCLC) leads with 14 active protocols, driven by combination immunotherapy and targeted therapy studies. Breast cancer follows with 10 active studies spanning HER2-positive, triple-negative, and hormone receptor-positive subtypes. Colorectal cancer accounts for 8 studies, with increasing emphasis on microsatellite instability-high (MSI-H) and deficient mismatch repair (dMMR) biomarker-selected populations. Melanoma rounds out the portfolio with 6 studies focused on adjuvant immunotherapy and novel combination approaches, with the remaining 4 studies distributed across renal cell carcinoma, hepatocellular carcinoma, and head and neck squamous cell carcinoma.
Immuno-oncology combinations represent the fastest-growing subsegment, now comprising over 60% of new oncology protocols entering our network. The shift from monotherapy immune checkpoint inhibitor studies toward combination regimens — pairing checkpoint inhibitors with targeted therapies, chemotherapy, or novel immunomodulators — has fundamentally changed enrollment dynamics, site requirements, and safety monitoring expectations.
Key Performance Metrics
Network-wide benchmarks from our oncology portfolio provide critical reference points for study planning and site performance evaluation.
Across all solid tumor indications, our network sites achieve a median enrollment rate of 1.8 patients per site per month. NSCLC and breast cancer studies consistently exceed this benchmark at 2.1 and 2.0 patients per site per month respectively, while biomarker-selected studies in CRC average 1.2 patients per site per month due to higher screening requirements.
Screen failure rates across the oncology portfolio average 38%, with significant variation by biomarker complexity. Studies requiring single biomarker confirmation average 28% screen failure, while multi-biomarker panels or companion diagnostic requirements push screen failure rates to 48-55%, substantially impacting enrollment velocity and cost per patient.
From contract execution to first patient enrolled, oncology sites within the network achieve a median startup time of 14.2 weeks. Sites with established tumor boards and biomarker testing infrastructure consistently achieve startup 3-4 weeks faster than sites requiring external laboratory partnerships for genomic profiling.
The overall patient retention rate across oncology studies is 84%, reflecting the high motivation of oncology patients to remain on study. Retention is highest in first-line treatment studies (89%) and lowest in heavily pre-treated populations enrolled in late-line studies (76%), where disease progression and adverse events drive discontinuation.
Network Capabilities
Executing oncology trials at the pace and complexity required by modern protocols demands specific infrastructure, expertise, and operational processes that not every clinical research site can deliver. Our network has been intentionally developed to ensure deep oncology-specific capabilities across every participating site.
Biomarker Testing Infrastructure
The majority of new oncology protocols require molecular testing as part of the screening process. Our network sites maintain established relationships with CLIA-certified molecular pathology laboratories and offer on-site or rapid-turnaround biomarker testing including next-generation sequencing (NGS) panels, immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), and polymerase chain reaction (PCR)-based assays. Sites with in-house molecular pathology capabilities achieve biomarker results 5-7 business days faster than sites relying on external send-out laboratories, directly accelerating the screening-to-enrollment conversion timeline.
For studies requiring comprehensive genomic profiling (CGP), 78% of our oncology sites have direct integration with foundation-level CGP platforms, enabling reflex testing from existing diagnostic specimens and reducing the need for additional biopsies that can delay enrollment and increase screen failure rates.
Tumor Board Integration
Multi-disciplinary tumor boards serve as a critical patient identification channel for clinical trial enrollment. Sites within our network participate in weekly or biweekly tumor boards that include medical oncology, surgical oncology, radiation oncology, pathology, and radiology representation. Clinical research coordinators are embedded in tumor board workflows, enabling real-time identification of patients who may qualify for active protocols. This integration yields an estimated 25-30% increase in pre-screening referrals compared to sites where clinical research operates independently of the tumor board process.
Phase I Unit Capabilities
Early-phase oncology trials require dedicated infrastructure including 24-hour pharmacokinetic sampling capabilities, dose escalation safety monitoring protocols, intensive adverse event management, and immediate access to emergency medical intervention. Fifteen sites within our network operate dedicated Phase I oncology units with trained clinical pharmacology staff, real-time telemetry monitoring, and standardized dose-limiting toxicity (DLT) assessment procedures. These units support first-in-human studies, dose-finding designs, and food-effect/drug-interaction substudies.
Infusion & Pharmacy Infrastructure
The shift toward biologic and antibody-based therapies means that the vast majority of oncology investigational products require intravenous administration. Network sites maintain dedicated research infusion suites with capacity for multi-hour infusions, pre-medication protocols, and infusion reaction monitoring. Research pharmacies are equipped for investigational product storage including controlled-temperature and light-protected conditions, with established chain-of-custody documentation and drug accountability procedures that meet sponsor and regulatory audit standards.
Enrollment Dynamics
Oncology enrollment patterns are shaped by a unique combination of factors that distinguish this therapeutic area from virtually every other. Understanding these dynamics is essential for realistic enrollment planning and site management.
Enrollment velocity in oncology varies dramatically by tumor type and line of therapy. First-line studies in prevalent tumor types like NSCLC and breast cancer benefit from large addressable patient populations and strong physician awareness, enabling sites to screen 3-5 patients per month. In contrast, biomarker-selected studies in later lines of therapy — such as third-line CRC with specific RAS/BRAF mutations — may see only 1-2 screenings per month even at high-volume sites, requiring larger site portfolios and longer enrollment windows.
Screen failure driven by biomarker requirements represents the single largest operational challenge in oncology enrollment. As protocols increasingly require specific molecular profiles for eligibility, the gap between patients who are clinically appropriate and patients who are molecularly eligible continues to widen. Our network data shows that screen failure rates due to biomarker ineligibility alone account for 60-70% of all screen failures in biomarker-selected oncology studies.
Community oncology sites are emerging as a critical enrollment channel. Historically, oncology trials were concentrated at academic medical centers, but the shift toward community-based care means that over 70% of cancer patients in the United States receive treatment in community settings. Our network has strategically expanded community oncology participation, and these sites now contribute 45% of oncology enrollments — with competitive screen-to-enrollment ratios and often faster startup times compared to their academic counterparts.
Key Challenges in Oncology Trial Execution
The increasing complexity of oncology protocols presents operational challenges that require specialized strategies and infrastructure.
Companion Diagnostic Integration
Modern oncology protocols frequently require companion diagnostic (CDx) assays as a gating criterion for enrollment. Coordinating CDx testing with enrollment timelines introduces logistical complexity: specimens must be collected, processed, shipped to designated laboratories, and results returned before screening windows close. Our network addresses this through pre-established CDx laboratory partnerships, standardized specimen collection kits maintained at each site, and dedicated biomarker coordinators who manage the testing workflow independently of the clinical coordinator team. Sites with integrated CDx pathways reduce the median time from specimen collection to result delivery by 40% compared to ad hoc arrangements.
Adaptive Design Complexity
Oncology leads all therapeutic areas in adoption of adaptive trial designs, including seamless Phase I/II designs, basket and umbrella trials, platform trials, and response-adaptive randomization. These designs require sites to manage multiple treatment arms simultaneously, respond to interim analysis-driven protocol amendments, and maintain blinding integrity across complex randomization schemes. Our network sites undergo adaptive design training prior to study initiation, including simulation exercises that model arm-dropping, sample size re-estimation, and biomarker-driven cohort expansion scenarios. Sites with adaptive design experience demonstrate 30% fewer protocol deviations related to randomization and treatment assignment errors.
Patient Diversity in Oncology
Despite cancer affecting all demographic groups, clinical trial participation remains disproportionately skewed toward white, non-Hispanic patients. Industry data shows that Black patients represent approximately 12% of new cancer diagnoses but only 3-5% of oncology trial enrollees. Our network addresses this disparity through strategic site placement in communities with diverse populations, culturally competent informed consent processes, multilingual coordinator staffing, and transportation assistance programs that reduce access barriers. Sites participating in our diversity enrollment initiative have achieved a 2.4x improvement in enrollment of underrepresented populations compared to national oncology trial averages.
Safety Monitoring in Immunotherapy
Immune-related adverse events (irAEs) present a distinct safety monitoring challenge that requires oncology-specific expertise. Unlike cytotoxic chemotherapy toxicities, irAEs can affect virtually any organ system, may present weeks or months after treatment initiation, and require immunosuppressive management that differs fundamentally from traditional supportive care. Our network sites maintain irAE management protocols aligned with ASCO, NCCN, and ESMO guidelines, with 24/7 on-call coverage by investigators experienced in irAE grading and management. Standardized irAE reporting templates ensure consistent, high-quality safety data across the network.
Pipeline Analysis
The oncology development pipeline continues to expand in both volume and complexity, with several therapeutic modalities driving significant shifts in trial design, site requirements, and enrollment planning.
Checkpoint Inhibitor Combinations
While the first wave of checkpoint inhibitor monotherapy approvals has matured, the next generation of studies focuses on rational combinations that enhance anti-tumor immune responses. PD-1/PD-L1 inhibitors are being paired with CTLA-4 inhibitors, LAG-3 antibodies, TIGIT inhibitors, and novel co-stimulatory agonists. These combination studies require more intensive safety monitoring, longer infusion times, and complex dosing schedules that increase the operational burden on participating sites. Our network is currently executing 18 combination immunotherapy protocols across multiple tumor types.
Bispecific Antibodies
Bispecific antibodies that simultaneously engage tumor antigens and immune effector cells represent one of the most active areas of oncology development. These agents frequently require step-up dosing protocols with extended first-dose monitoring periods (often 24-48 hours) and cytokine release syndrome (CRS) management capabilities. Sites participating in bispecific studies must have access to tocilizumab or equivalent CRS management agents, intensive monitoring beds, and staff trained in CRS grading and intervention protocols. Seven of our network sites have been certified for bispecific antibody studies with full CRS management infrastructure.
Antibody-Drug Conjugates (ADCs)
ADCs continue to demonstrate transformative efficacy across multiple tumor types, driving a surge in late-phase clinical programs. The ADC pipeline has expanded from HER2-targeted agents into broader target landscapes including Trop-2, Nectin-4, CEACAM5, and FRa. ADC studies present unique site requirements including specialized adverse event monitoring for payload-related toxicities (particularly interstitial lung disease, neuropathy, and ocular toxicity), ophthalmology referral pathways, and pulmonary function testing capabilities. Our network maintains ADC-specific safety monitoring protocols and established referral relationships with pulmonology and ophthalmology subspecialists.
Cell Therapy & Combination Regimens
CAR-T and TCR-based cell therapies are expanding beyond hematologic malignancies into solid tumors. While solid tumor cell therapy is still predominantly early-phase, the pipeline is growing rapidly with TIL therapy, CAR-T targeting solid tumor antigens, and combination approaches pairing cell therapy with checkpoint inhibitors. These studies require apheresis capabilities, complex chain-of-custody management for manufactured products, lymphodepleting chemotherapy administration, and intensive post-infusion monitoring for CRS and neurotoxicity. Four network sites have established cell therapy programs with full apheresis-to-monitoring capabilities.
Site Requirements for Oncology Excellence
The infrastructure, staffing, and operational processes required to execute modern oncology protocols at the highest level of quality.
Dedicated research pharmacy with temperature-controlled storage (including -20C and -80C freezers), hazardous drug handling per USP 800 guidelines, automated drug accountability systems, and pharmacist availability during all infusion hours. Oral oncology studies additionally require dispensing logs and adherence monitoring infrastructure.
Minimum of 4 dedicated research infusion chairs with cardiac monitoring capability, pre-medication and post-infusion observation areas, anaphylaxis emergency equipment, and scheduling systems that accommodate multi-hour infusion windows without displacing standard-of-care treatment capacity.
On-site or rapid-access CT, MRI, and PET-CT capabilities with RECIST 1.1-trained radiologists for tumor response assessment. Sites must maintain consistent imaging protocols across timepoints and support central imaging vendor upload requirements for blinded independent central review (BICR).
24/7 investigator availability for serious adverse event assessment, established relationships with subspecialty consultants (pulmonology, cardiology, endocrinology, neurology) for irAE management, and standardized AE grading using CTCAE v5.0 criteria with quality oversight by medical monitors.
Central and local laboratory capabilities including same-day CBC with differential, comprehensive metabolic panel, thyroid function, and specialized assays (e.g., cortisol, troponin) required for immunotherapy safety monitoring. Specimen processing and shipping for PK/PD and translational biomarker samples.
Dedicated oncology clinical research coordinators with tumor-specific training, research nurses certified in chemotherapy/biotherapy administration, data managers with EDC proficiency, and regulatory coordinators managing IRB submissions and protocol amendments on active timelines.
Discuss Your Oncology Program
Connect with our team to explore site capabilities, enrollment strategies, and biomarker infrastructure for your oncology clinical development program.