Small-cell Lung CancerPhase 3TRIPLEXNCT05223647
Chemo-immunotherapy Plus Thoracic Radiotherapy in Extensive Stage Small-cell Lung Cancer
A Phase 3 study testing Thoracic radiotherapy and Chemo-immunotherapy in people with Small-cell Lung Cancer, run by Norwegian University of Science and Technology at 20 sites in 5 countries.
Trial summary
Studies have shown that combining chemotherapy and immune checkpoint inhibitors (ICI) prolongs survival compared with chemotherapy alone in extensive stage small-cell lung cancer (ES SCLC), but the survival benefit is modest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-cell Lung Cancer
- What is being tested?
- Thoracic radiotherapy and Chemo-immunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 11 Jan 2022to 4 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years at time of study entry
- ECOG performance status of 0 or 1
- Body weight >30 kg
- Adequate bone marrow, liver and kidney function
- Life expectancy of at least 3 months
- At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 30 Gy/10 fractions
Show all 10Show fewer
- Histologically or cytologically confirmed SCLC
- Stage III-IV disease (TNM v8)
- FEV1 >1 L or >30 % of predicted value and DLCO >30 % of predicted value
- Patients with brain metastases are eligible provided they are asymptomatic or treated and stable on steroids and/or anticonvulsants prior to the start of treatment
Who cannot join
- Previous chemo-, immuno- or radiotherapy for SCLC
- Major surgical procedure last 28 days
- History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
- Uncontrolled intercurrent illness
- Other active malignancy
- Leptomeningeal carcinomatosis
- Immunosuppressive medication
- Pregnant or breastfeeding women
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
Norway12 sites
Ålesund Hospital
Ålesund
Haukeland Universitetssykehus
Bergen
Nordlandssykehuset HF
Bodø
Drammen sykehus - Vestre Viken
Drammen
Innlandet hospital Gjøvik
Gjøvik
Haugesund hospital
Haugesund
Sykehuset Levanger
Levanger
Akershus Universitetssykehus AHUS
Oslo
Oslo University Hospital Ullevål
Oslo
Stavanger University Hospital
Stavanger
University Hospital of North Norway, Pulmonology Department
Tromsø
Cancer Clinic at St. Olavs Hospital
Trondheim
Sweden5 sites
Gävle hospital
Gävle
Sahlgrenska Sjukehuset
Gothenburg
Linköping University Hospital
Linköping
Lund University Hospital
Skåne
Karolinska University Hospital
Stockholm
About this study
Official title: Randomized Phase III Trial Investigating the Survival Benefit of Adding Thoracic Radiotherapy to Durvalumab (MEDI4736) Immunotherapy Plus Chemotherapy in Extensive Stage Small-cell Lung Cancer
Studies have shown that combining chemotherapy and immune checkpoint inhibitors (ICI) prolongs survival compared with chemotherapy alone in extensive stage small-cell lung cancer (ES SCLC), but the survival benefit is modest. The main aim of this trial is to investigate whether there is a synergistic/additive effect of concurrent thoracic radiotherapy in ES SCLC patients receiving carboplatin/etoposide/durvalumab.
Read the detailed description
Studies show that adding ICI therapy to standard chemotherapy prolongs survival in ES SCLC. The survival benefit, however, is modest, and there is a need for more effective therapy. It has been hypothesized that there is a synergistic effect of combining ICI with radiotherapy. In this randomized phase III study, the main aim is to investigate whether concurrent thoracic radiotherapy of 30 Gy/10 fractions improves survival in ES SCLC patients receiving carboplatin/etoposide/durvalumab.
It is currently not possible to classify the patients who benefit from ICIs in SCLC. In this study, biological material (tissue, blood, feces) which will be analyzed for potential predictive and prognostic biomarkers.
Prophylactic cranial irradiation in ES SCLC is debated, mainly due to the potentially detrimental effect on cognition. Thus, frequency and timing of brain metastases and cognitive function will be assessed before, during and after study treatment.
- Conditions
- Small-cell Lung Cancer
- Being tested
- Thoracic radiotherapy, Chemo-immunotherapy
- Keywords
- cancer, chemotherapy, radiotherapy, immunotherapy
- Medical subject headings
- Small Cell Lung Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic radiotherapyProcedure or surgery
30Gy/10 fractions thoracic radiotherapy given between 2nd and 3rd course of chemo-immunotherapy.
Chemo-immunotherapyDrug
Also called carboplatin/etoposide/durvalumab
Four courses of carboplatin/etoposide/durvalumab every 3 weeks followed by durvalumab every 4 weeks until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment.
| Study group | Role | What they receive |
|---|---|---|
| Chemo-immunotherapy plus thoracic radiotherapy | Experimental | Four courses of carboplatin/etoposide/durvalumab every 3 weeks followed by durvalumab every 4 weeks until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment.
Thoracic radiotherapy of 30 Gy/10 fractions between 2nd and 3rd carboplatin/etoposide/durvalumab course. Receives: Procedure: Thoracic radiotherapy; Drug: Chemo-immunotherapy |
| Chemo-immunotherapy | Active comparator | Four courses of carboplatin/etoposide/durvalumab every 3 weeks followed by durvalumab every 4 weeks until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment. Receives: Drug: Chemo-immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 1-year overall survival
The Cox proportional hazards method will be used to compare survival between the treatment groups.
Measured: 14 months after last patient entry
Secondary outcomes (7)
Change in 2-, 3-, 4- and 5-year survival rate
The Cox proportional hazards method will be used to compare survival between the treatment groups.
Measured: 2, 3, 4 and 5 years after last patient entry
Frequency and severity of adverse events
Adverse events will be compared between the treatment arms using the Pearson's Chi-square and Fisher's exact test.
Measured: Through study completion, an average of 1 year after last patient entry
Change in progression free survival (PFS)
PFS will be estimated using the Kaplan-Meier method and compared using the log-rank test. A Cox-model adjusting for baseline characteristics will be used for multivariable analyses.
Measured: Through study completion, an average of 1 year after last patient entry
Change in overall response rates
Response rates are compared using Pearson's Chi-square test.
Measured: Through study completion, an average of 1 year after last patient entry
Change in response rates in non-irradiated lesions
Response rates are compared using Pearson's Chi-square test.
Measured: Through study completion, an average of 1 year after last patient entry
Local control rates in the thorax
Local control rates are compared using Pearson's Chi-square test.
Measured: Through study completion, an average of 1 year after last patient entry
Health-related quality of life (HRQoL)
All HRQoL scores will be transformed to a scale of 0-100 according to the EORTC QLQ scoring manual. Mean scores will be compared at each assessment timepoint, and a difference of 10 points is considered clinically relevant.
Measured: Through study completion, an average of 1 year after last patient entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start11 Jan 2022
- Primary completion4 Sep 2025
- Study completion4 Sep 2025
Why it stopped: Termination was adviced by Data Safety Committee due to excess toxicity of the experimental treatment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Haukeland University Hospital, University Hospital of North Norway, Alesund Hospital, Helse Stavanger HF, Oslo University Hospital, Helse Nord-Trøndelag HF, Helse Fonna, Drammen sykehus, University Hospital, Akershus, Erasmus Medical Center, Sahlgrenska University Hospital, Karolinska University Hospital, Gävle Hospital, Sykehuset Innlandet HF, North Estonia Medical Centre, Nordlandssykehuset HF, Landspitali University Hospital, Lund University Hospital, University Hospital, Linkoeping
- Responsible party
- Sponsor
- Investigators
- Magnus Steigedal, PhD, Study director, Department of Clinical and Molecular Medicine, NTNU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223647
- Sponsor's protocol ID
- EC#230766
- Other IDs
- 2020203
- Acronym
- TRIPLEX
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2022
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results, including biomarker analyses, will be made available in Sponsor's data repository based on the data management plan and according to FAIR principles.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Trial Investigating the Survival Benefit of Adding Thoracic Radiotherapy to Durvalumab (MEDI4736) Immunotherapy Plus Chemotherapy in Extensive Stage Small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05223647
- Acronym / sponsor ID
- TRIPLEX / EC#230766
- Conditions
- Small-cell Lung Cancer
- Keywords
- cancer, chemotherapy, radiotherapy, immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination was adviced by Data Safety Committee due to excess toxicity of the experimental treatment.
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Haukeland University Hospital, University Hospital of North Norway, Alesund Hospital, Helse Stavanger HF, Oslo University Hospital, Helse Nord-Trøndelag HF, Helse Fonna, Drammen sykehus, University Hospital, Akershus, Erasmus Medical Center, Sahlgrenska University Hospital, Karolinska University Hospital, Gävle Hospital, Sykehuset Innlandet HF, North Estonia Medical Centre, Nordlandssykehuset HF, Landspitali University Hospital, Lund University Hospital, University Hospital, Linkoeping
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studies have shown that combining chemotherapy and immune checkpoint inhibitors (ICI) prolongs survival compared with chemotherapy alone in extensive stage small-cell lung cancer (ES SCLC), but the survival benefit is modest. The main aim of this trial is to investigate whether there is a synergistic/additive effect of concurrent thoracic radiotherapy in ES SCLC patients receiving carboplatin/etoposide/durvalumab.
Detailed description
Studies show that adding ICI therapy to standard chemotherapy prolongs survival in ES SCLC. The survival benefit, however, is modest, and there is a need for more effective therapy. It has been hypothesized that there is a synergistic effect of combining ICI with radiotherapy. In this randomized phase III study, the main aim is to investigate whether concurrent thoracic radiotherapy of 30 Gy/10 fractions improves survival in ES SCLC patients receiving carboplatin/etoposide/durvalumab.
It is currently not possible to classify the patients who benefit from ICIs in SCLC. In this study, biological material (tissue, blood, feces) which will be analyzed for potential predictive and prognostic biomarkers.
Prophylactic cranial irradiation in ES SCLC is debated, mainly due to the potentially detrimental effect on cognition. Thus, frequency and timing of brain metastases and cognitive function will be assessed before, during and after study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemo-immunotherapy plus thoracic radiotherapy | Experimental | Procedure: Thoracic radiotherapy, Drug: Chemo-immunotherapyFour courses of carboplatin/etoposide/durvalumab every 3 weeks followed by durvalumab every 4 weeks until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment. Thoracic radiotherapy of 30 Gy/10 fractions between 2nd and 3rd carboplatin/etoposide/durvalumab course. |
| Chemo-immunotherapy | Active comparator | Drug: Chemo-immunotherapyFour courses of carboplatin/etoposide/durvalumab every 3 weeks followed by durvalumab every 4 weeks until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 18 years at time of study entry
- ECOG performance status of 0 or 1
- Body weight >30 kg
- Adequate bone marrow, liver and kidney function
- Life expectancy of at least 3 months
Key exclusion criteria (8 listed)
- Previous chemo-, immuno- or radiotherapy for SCLC
- Major surgical procedure last 28 days
- History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
- Uncontrolled intercurrent illness
- Other active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic radiotherapy30Gy/10 fractions thoracic radiotherapy given between 2nd and 3rd course of chemo-immunotherapy. | Procedure or surgery | Chemo-immunotherapy plus thoracic radiotherapy |
| Chemo-immunotherapyAlso: carboplatin/etoposide/durvalumabFour courses of carboplatin/etoposide/durvalumab every 3 weeks followed by durvalumab every 4 weeks until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment. | Drug | Chemo-immunotherapy, Chemo-immunotherapy plus thoracic radiotherapy |
Primary outcome
Change in 1-year overall survival
Time frame: 14 months after last patient entry
The Cox proportional hazards method will be used to compare survival between the treatment groups.
7 secondary outcomes
Change in 2-, 3-, 4- and 5-year survival rate
Time frame: 2, 3, 4 and 5 years after last patient entry
Frequency and severity of adverse events
Time frame: Through study completion, an average of 1 year after last patient entry
Change in progression free survival (PFS)
Time frame: Through study completion, an average of 1 year after last patient entry
Change in overall response rates
Time frame: Through study completion, an average of 1 year after last patient entry
Change in response rates in non-irradiated lesions
Time frame: Through study completion, an average of 1 year after last patient entry
Local control rates in the thorax
Time frame: Through study completion, an average of 1 year after last patient entry
Health-related quality of life (HRQoL)
Time frame: Through study completion, an average of 1 year after last patient entry
Results and safety
The study was stopped early (reason given: Termination was adviced by Data Safety Committee due to excess toxicity of the experimental treatment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Yes. Results, including biomarker analyses, will be made available in Sponsor's data repository based on the data management plan and according to FAIR principles.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Steigedal, PhD study director
Department of Clinical and Molecular Medicine, NTNU
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thoracic radiotherapy and Chemo-immunotherapy in people with Small-cell Lung Cancer, run by Norwegian University of Science and Technology at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Norway, Sweden, Estonia, Iceland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Termination was adviced by Data Safety Committee due to excess toxicity of the experimental treatment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 1-year overall survival (time frame: 14 months after last patient entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.