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Strategic Analysis
Winning proposals must deliver a robust, academic investigator-initiated pragmatic clinical trial (@SC1) that generates definitive real-world clinical and socio-economic evidence for optimizing immunotherapeutic interventions in refractory cancer patients. A successful strategy will tightly integrate co-designed patient-centric primary and secondary endpoints (@SC3)—including overall survival and patient-reported outcomes—with healthcare system implementation and reimbursement pathways (@EO3) across diverse European regions.
TRL 2 → 6
Based on programme defaults
Conduct randomised or cluster-randomised academic investigator-initiated [2] pragmatic clinical trials that benefit patients with refractory cancers - at any stage of the disease, for any cancer subtype, in any age group or part of society - to deliver effective, affordable and tailored immunotherapeutic interventions for implementation by healthcare systems at the level of local communities, European regions, EU Member States and Associated Countries.
All data should be disaggregated by sex, gender, age and other relevant variables, such as by measures of socio-economic status or ethnicity. Translational research is limited to supporting biomarker-informed patient stratification and the conduct and analyses of the proposed clinical trial(s).
The primary and secondary endpoints of the pragmatic clinical trials should target overall survival, patient-reported outcomes and quality of life issues considered important by and for cancer patients and their caregivers/families. Such endpoints should be defined together with patients and their caregivers/families through research that stimulates social innovation and supports end-user engagement using participative research models.
The chosen treatment intervention(s) should be adapted to the particular needs of the target population and to the specificities of the provision of care at local, regional, or national level, duly reflecting the diversity across EU Member States and Associated Countries. Furthermore, affordability and accessibility should be taken into account.
Applicants should include an appropriate mix of stakeholders from various disciplines, sectors [3] and regional as well as national health authorities, and provide details of the clinical study(ies) in the dedicated annex using the template provided in the submission system.
Patients with refractory cancers and their caregivers/families will have access to optimised, tailored and affordable immunotherapeutic interventions that increase their quality of life, across European regions, EU Member States and Associated Countries;
Healthcare professionals and academia will have access to clinical evidence, on effectiveness of immunotherapeutic interventions, to deploy evidence-based treatment interventions with improved patient selection that improve outcomes in real life, i.e. in routine healthcare, for patients with refractory cancers who often present with co-morbidities;
National healthcare providers, policymakers and authorities in European regions, EU Member States and Associated Countries will have the evidence to implement and reimburse optimised and affordable immunotherapeutic interventions in their healthcare systems, including in everyday medical practice.
No expected impacts identified for this destination.
EU Cancer Mission
highThe EU Mission on Cancer is a major initiative under Horizon Europe aiming to improve the lives of more than 3 million people by 2030 through prevention, cure, and better quality of life for cancer patients and survivors. It operates alongside Europe's Beating Cancer Plan to foster innovative research, support clinical progress, and integrate solutions into healthcare systems across Europe.
Evaluators expect proposals to explicitly address the goals of the EU Cancer Mission by demonstrating how the research will deliver clear, patient-centric benefits, improve clinical practice, and generate robust evidence to optimise treatment strategies for cancer patients.
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described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes.
Proposal page limits and layout: described in Part B of the Application Form available in the Submission System.
described in Annex B of the Work Programme General Annexes.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.
described in Annex B of the Work Programme General Annexes.
described in Annex C of the Work Programme General Annexes.
are described in Annex D of the Work Programme General Annexes.
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold is 12.
are described in Annex F of the Work Programme General Annexes and the Online Manual.
described in Annex F of the Work Programme General Annexes.
Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025) [[This decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf]].
The granting authority may, up to 4 years after the end of the action, object to a transfer of ownership or to the exclusive licensing of results, as set out in the specific provision of Annex 5.
described in Annex G of the Work Programme General Annexes.
described in the [specific topic of the Work Programme]
Application form templates — the application form specific to this call is available in the Submission System
Standard application form (HE RIA, IA)
Guidance
Model Grant Agreements (MGA)
Call-specific instructions
Information on clinical studies (HE)
Guidance: "Lump sums - what do I need to know?"
HE Main Work Programme 2026-2027 – 1. General Introduction
HE Main Work Programme 2026-2027 – 12. Missions
HE Main Work Programme 2026-2027 – 15. General Annexes
HE Framework Programme 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation 2024/2509
Decision authorising the use of lump sum contributions under the Horizon Europe Programme
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Evaluators will prioritize proposals that demonstrate true pragmatic clinical trial design rather than highly controlled efficacy trials. They will closely examine:
Everything the call asks for, seen from the call's point of view. Each line shows what answers it, and which partner carries it.
This matrix lists everything the call asks for: outcomes, impacts, scope, the requirements buried in the call text, and policy alignment. Sign up free and GrantForge tracks each line against the concept you build.
| Requirement | Covered by | Carried | Status |
|---|---|---|---|
| Scope activities | |||
| SC1Conduct randomised or cluster-randomised academic investigator-initiated [2] pragmatic clinical trials that benefit patients with refractory cancers - at any stage of the disease, for any cancer subtype, in any age group or part of society - to deliver effective, affordable and tailored immunotherapeutic interventions for implementation by healthcare systems at the level of local communities, European regions, EU Member States and Associated Countries. | · | · | Sign up to track |
| SC2All data should be disaggregated by sex, gender, age and other relevant variables, such as by measures of socio-economic status or ethnicity. Translational research is limited to supporting biomarker-informed patient stratification and the conduct and analyses of the proposed clinical trial(s). | · | · | Sign up to track |
| SC3The primary and secondary endpoints of the pragmatic clinical trials should target overall survival, patient-reported outcomes and quality of life issues considered important by and for cancer patients and their caregivers/families. Such endpoints should be defined together with patients and their caregivers/families through research that stimulates social innovation and supports end-user engagement using participative research models. | · | · | Sign up to track |
| SC4The chosen treatment intervention(s) should be adapted to the particular needs of the target population and to the specificities of the provision of care at local, regional, or national level, duly reflecting the diversity across EU Member States and Associated Countries. Furthermore, affordability and accessibility should be taken into account. | · | · | Sign up to track |
| SC5Applicants should include an appropriate mix of stakeholders from various disciplines, sectors [3] and regional as well as national health authorities, and provide details of the clinical study(ies) in the dedicated annex using the template provided in the submission system. | · | · | Sign up to track |
| Expected outcomes | |||
| EO1Patients with refractory cancers and their caregivers/families will have access to optimised, tailored and affordable immunotherapeutic interventions that increase their quality of life, across European regions, EU Member States and Associated Countries; | · | · | Sign up to track |
| EO2Healthcare professionals and academia will have access to clinical evidence, on effectiveness of immunotherapeutic interventions, to deploy evidence-based treatment interventions with improved patient selection that improve outcomes in real life, i.e. in routine healthcare, for patients with refractory cancers who often present with co-morbidities; | · | · | Sign up to track |
| EO3National healthcare providers, policymakers and authorities in European regions, EU Member States and Associated Countries will have the evidence to implement and reimburse optimised and affordable immunotherapeutic interventions in their healthcare systems, including in everyday medical practice. | · | · | Sign up to track |
| Other requirements | |||
| REQ1Sex, gender, age, and socio-economic data disaggregationAll clinical and research data must be disaggregated by sex, gender, age, and other relevant variables such as socio-economic status or ethnicity. | · | · | Sign up to track |
| REQ2Patient and caregiver participatory co-designPrimary and secondary endpoints must be co-defined with patients and their caregivers/families through research that stimulates social innovation and end-user engagement. | · | · | Sign up to track |
| REQ3Multi-stakeholder and cross-sectoral engagementProposals must involve an appropriate mix of stakeholders across disciplines and sectors, including regional and national health authorities. | · | · | Sign up to track |
| REQ4Synergies with Knowledge Centre on Cancer (KCC)Successful proposals are expected to build on resources made available by the Knowledge Centre on Cancer (KCC) to foster EU alignment and coordination. | · | · | Sign up to track |
| REQ5Participation in EU Cancer Mission Diagnosis and Treatment clusterProjects will be required to join the 'Diagnosis and Treatment' cluster for the EU Cancer Mission and allocate dedicated budget for networking, meetings, and joint activities. | · | · | Sign up to track |
| Expected impacts | |||
| No expected impacts in this call. | |||
| Underlying policies | |||
| POL1eu cancer missionThe EU Mission on Cancer is a major initiative under Horizon Europe aiming to improve the lives of more than 3 million people by 2030 through prevention, cure, and better quality of life for cancer patients and survivors. It operates alongside Europe's Beating Cancer Plan to foster innovative research, support clinical progress, and integrate solutions into healthcare systems across Europe. | · | · | Sign up to track |
The binding rules of this call. Items marked auto are verified by GrantForge from the call and the template. The others are yours to confirm.
LMIC entities auto-eligible
Low/middle-income country entities are automatically eligible for funding.
EU space data infrastructures
If the project uses satellite-based Earth observation, positioning, navigation or timing data/services, beneficiaries must use Copernicus and/or Galileo/EGNOS. Other sources may be added but not substitute EU infrastructures.
Civil applications only
Horizon Europe funds exclusively civil applications. Research with exclusive military or dual-use application is excluded.
Gender Equality Plan
Having a Gender Equality Plan (GEP) is an eligibility criterion for public bodies, research organisations, and higher education institutions from Member States and Associated Countries.
Open Science
Mandatory open access to peer-reviewed scientific publications and responsible management of research data (FAIR principles, DMP required).
5 key insights you must internalise before writing. Each is grounded in the call text and tells you what evaluators will actually look for. Share these with your consortium before drafting.
Evaluators are explicitly instructed to prioritize true pragmatic clinical trial designs over highly controlled efficacy trials. Proposals must evaluate interventions in settings that closely resemble routine, real-world healthcare rather than artificially restricted clinical environments. Overly strict inclusion criteria will severely damage the evaluation score.
Source: evaluation_pre_award
A consortium lacking regional or national health authorities and HTA bodies will fail the impact evaluation. These stakeholders must be actively involved to guarantee the post-trial implementation, reimbursement, and cross-border affordability of the immunotherapeutic interventions.
Source: evaluation_pre_award
Clinical endpoints cannot be dictated solely by academic trialists. The proposal must use social innovation and participative research models to co-design primary and secondary endpoints—specifically overall survival and patient-reported outcomes—directly with patients and their caregivers.
Source: scope
Proposals must avoid extensive exploratory research. The call strictly limits translational research to biomarker-informed patient stratification and the direct conduct and analysis of the proposed clinical trials.
Source: scope
As a Lump Sum action, evaluators will closely examine the Lump Sum budget breakdown and the mandatory clinical study annex. The financial planning must transparently align with the trial methodology, meaning payment milestones must be strategically tied to realistic patient recruitment and trial execution phases.
Source: evaluation_pre_award
Talk to the Grant Coach to build your concept. The steps below fill in as it takes shape, and your coverage tracks the progress. You can refine everything once your project workspace is created.
Step 1 of 2 · Build your concept
The problems this call frames, and who they affect. Your concept and plan address them.
Conventional clinical trials frequently exclude refractory cancer patients with co-morbidities or low socio-economic status, resulting in a lack of pragmatic evidence on treatment effectiveness in routine clinical care.
Standard clinical trials often neglect endpoints that matter most to patients and caregivers, such as long-term quality of life and functional independence, leading to interventions that fail end-user priorities.
Disparities in regional healthcare infrastructures and high drug costs create severe inequalities in access to immunotherapies across EU Member States and Associated Countries.
Refractory cancer patients across all age groups, disease stages, and socio-economic backgrounds, alongside their family caregivers who directly benefit from optimized treatment access and improved quality of life.
Clinical staff in routine healthcare settings who require actionable clinical evidence to prescribe tailored immunotherapies for complex patients with co-morbidities.
National and regional health technology assessment agencies, healthcare system managers, and reimbursement decision-makers.
Academic researchers, oncology networks, and clinical trial trialists who utilize trial datasets, biomarker stratification methodologies, and participative research frameworks.
Step 2 of 2 · Build your concept
The long-term impacts your project should drive — this shapes the objectives next.
Delivers pragmatic, patient-centered clinical evidence that directly enhances overall survival and quality of life for refractory cancer patients across EU regions (@EO1).
Empowers clinical practitioners with robust evidence for biomarker-guided patient selection in real-world settings (@EO2).
Provides national healthcare systems with cost-effectiveness and pragmatic trial evidence required to formulate fair reimbursement policies (@EO3).