Non-small Cell Lung Cancer Stage IIINCT05557552
Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer
A study testing standar thoracic RT dose and decreased thoracic RT dose in people with Non-small Cell Lung Cancer Stage III, run by Ruijin Hospital at 1 site in China.
Trial summary
Concurrent chemoradiotherapy without disease progression followed by consolidation durvalumab is standard of care for unresectable, stage III non-small-cell lung cancer (NSCLC) (the 'PACIFIC regimen'). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small Cell Lung Cancer Stage III
- What is being tested?
- standar thoracic RT dose and decreased thoracic RT dose
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2022to 30 Sep 2026
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at time of study entry
- Histologically documented diagnosis of unresectable stage III NSCLC;
- Fully-informed written consent obtained from patients;
- Unfit for concurrent chemoradiotherapy as determined by the multi-disciplinary team board due to one of the following reasons: (1) ECOG 2; (2)age≥70;(3) ECOG 1 and CCI≥1；
- Adequate bone marrow, liver and kidney function
- Life expectancy of at least 3 months
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- At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated
- Histologic or cytologic confirmation of small cell lung cancer
- Adequate pulmonary function with FEV1 >1 L or >30 % of predicted value and DLCO >30 % of predicted value
Who cannot join
- Previous chemo-, immuno- or radiotherapy for NSCLC
- 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
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
Shanghai, Shanghai Municipality, 200025
Yifeng Wang, +862164370045, qwx12055@rjh.com.cn
Yi Xiang, Dr.
About this study
Official title: Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer Patients Unfit for Concurrent Chemoradiotherapy: an Open Label, Two Cohorts, Prospective Trial
Concurrent chemoradiotherapy without disease progression followed by consolidation durvalumab is standard of care for unresectable, stage III non-small-cell lung cancer (NSCLC) (the 'PACIFIC regimen'). However, many patients with poor performance status, older age or comorbidities may be ineligible for chemotherapy due to expected high toxicity. The present study aim to investigate the efficacy and toxicities of sequential chemo-immunotherapy plus thoracic radiotherapy for elderly and/or frail stage III NSCLC patients unfit for concurrent chemoradiotherapy, and to identify the optimal thoracic dose for this patient population.
- Conditions
- Non-small Cell Lung Cancer Stage III
- Being tested
- standar thoracic RT dose, decreased thoracic RT dose
- Keywords
- thoradic radiotherapy, non-small-cell lung cancer, chemo-immunotherapy, survival
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standar thoracic RT doseRadiation
All the enrolled patients will be patients with NSCLC who did not have PD (determined as per the RECIST v1.1) after 4-6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with standard dose thoracic radiotherapy of 60 Gy/30Fx concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.
decreased thoracic RT doseRadiation
All the enrolled patients will be patients with NSCLC who did not have PD (determined as per the RECIST v1.1) after 4-6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with decreased thoracic radiotherapy of 50Gy/25Fx concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.
| Study group | Role | What they receive |
|---|---|---|
| standar thoracic RT dose | Experimental | Sequential chemo-immunotherapy plus standard dose of thoracic radiotherapy followed by anti-PD-1/PD-L1 maintenance therapy Receives: Radiation: standar thoracic RT dose |
| decreased thoracic RT dose | Experimental | Sequential chemo-immunotherapy plus decreased thoracic radiotherapy followed by anti-PD-1/PD-L1 maintenance therapy Receives: Radiation: decreased thoracic RT dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
time from treatment start until death or progression of tumor disease within one year
Measured: 12 months after last patient entry
Secondary outcomes (3)
1-year overall survial
time from treatment start until death with in one year
Measured: 12 months after last patient entry
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 within one year
Safety and Tolerability
Measured: 12 months after last patient entry
5-year overall survival
Time from treatment start until death
Measured: 5-years 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 posted28 Sep 2022
- Study start30 Sep 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer Stage IIIStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengguang Zhao, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557552
- Sponsor's protocol ID
- 2021(189)
- Status last verified
- Nov 2023
- First submitted
- 21 Sep 2022
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qi WX, Li S, Wang M, Li H, Xu F, Yao L, Yu B, Chen L, Cai G, Xu C, Sun X, Bao Z, Chen J, Xiang Y, Zhao S. Sequential chemo-immunotherapy followed by standard versus reduced thoracic radiotherapy for older and/or frail stage III non-small-cell lung cancer: A randomized open-label cohort trial. PLoS Med. 2026 May 27;23(5):e1005111. doi: 10.1371/journal.pmed.1005111. eCollection 2026 May.
PubMed 42201929
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer Patients Unfit for Concurrent Chemoradiotherapy: an Open Label, Two Cohorts, Prospective Trial
- ClinicalTrials.gov ID
- NCT05557552
- Acronym / sponsor ID
- 2021(189)
- Conditions
- Non-small Cell Lung Cancer Stage III
- Keywords
- thoradic radiotherapy, non-small-cell lung cancer, chemo-immunotherapy, survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 28 Sep 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.
Concurrent chemoradiotherapy without disease progression followed by consolidation durvalumab is standard of care for unresectable, stage III non-small-cell lung cancer (NSCLC) (the 'PACIFIC regimen'). However, many patients with poor performance status, older age or comorbidities may be ineligible for chemotherapy due to expected high toxicity. The present study aim to investigate the efficacy and toxicities of sequential chemo-immunotherapy plus thoracic radiotherapy for elderly and/or frail stage III NSCLC patients unfit for concurrent chemoradiotherapy, and to identify the optimal thoracic dose for this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standar thoracic RT dose | Experimental | Radiation: standar thoracic RT doseSequential chemo-immunotherapy plus standard dose of thoracic radiotherapy followed by anti-PD-1/PD-L1 maintenance therapy |
| decreased thoracic RT dose | Experimental | Radiation: decreased thoracic RT doseSequential chemo-immunotherapy plus decreased thoracic radiotherapy followed by anti-PD-1/PD-L1 maintenance therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years at time of study entry
- Histologically documented diagnosis of unresectable stage III NSCLC;
- Fully-informed written consent obtained from patients;
- Unfit for concurrent chemoradiotherapy as determined by the multi-disciplinary team board due to one of the following reasons: (1) ECOG 2; (2)age≥70;(3) ECOG 1 and CCI≥1；
- Adequate bone marrow, liver and kidney function
Key exclusion criteria (8 listed)
- Previous chemo-, immuno- or radiotherapy for NSCLC
- 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 |
|---|---|---|
| standar thoracic RT doseAll the enrolled patients will be patients with NSCLC who did not have PD (determined as per the RECIST v1.1) after 4-6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with standard dose thoracic radiotherapy of 60 Gy/30Fx concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months. | Radiation | standar thoracic RT dose |
| decreased thoracic RT doseAll the enrolled patients will be patients with NSCLC who did not have PD (determined as per the RECIST v1.1) after 4-6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with decreased thoracic radiotherapy of 50Gy/25Fx concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months. | Radiation | decreased thoracic RT dose |
Primary outcome
progression-free survival
Time frame: 12 months after last patient entry
time from treatment start until death or progression of tumor disease within one year
3 secondary outcomes
1-year overall survial
Time frame: 12 months after last patient entry
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 within one year
Time frame: 12 months after last patient entry
5-year overall survival
Time frame: 5-years after last patient entry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Derived from this study: PubMed 42201929Qi WX, Li S, Wang M, Li H, Xu F, Yao L, Yu B, Chen L, Cai G, Xu C, Sun X, Bao Z, Chen J, Xiang Y, Zhao S. Sequential chemo-immunotherapy followed by standard versus reduced thoracic radiotherapy for older and/or frail stage III non-small-cell lung cancer: A randomized open-label cohort trial. PLoS Med. 2026 May 27;23(5):e1005111. doi: 10.1371/journal.pmed.1005111. eCollection 2026 May.
- Individual participant dataSharing planned: No
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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.
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standar thoracic RT dose and decreased thoracic RT dose in people with Non-small Cell Lung Cancer Stage III, run by Ruijin Hospital at 1 site in China.
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 9 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: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 12 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?
On the ClinicalTrials.gov record for NCT05557552, which also lists 1 linked publication.
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 23 Sep 2024.