Resectable/Potentially Resectable NSCLCNCT06243679
The Efficacy and Safety of Adjuvant Immunotherapy After Pathological Complete Response Following Neoadjuvant Chemoimmunotherapy in Patients with Resectable NSCLC
An observational study of Resectable/Potentially Resectable NSCLC, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This is a prospective, observational, multicenter real-world study aiming to investigate the efficacy and safety of NSCLC patients with or without adjuvant immunotherapy who have achieved pathologic complete remission after neoadjuvant immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Resectable/Potentially Resectable NSCLC
- What is being tested?
- Immunotherapy
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients diagnosed with resectable non-small cell lung cancer (NSCLC) who have received immune checkpoint inhibitor neoadjuvant therapy and achieved pathological complete response (pCR).
Who may be able to join
- 18 years ≤ age ≤ 80 years;
- Histologically or cytologically confirmed NSCLC;
- Resectable stage IB, II, IIIA, or IIIB (N2) NSCLC according to the staging criteria of the American Joint Committee on Cancer (8th edition);
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 at baseline;
- With measurable or evaluable diseases according to the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) at baseline;
- Achieving pathological complete response (pCR) after three cycles of neoadjuvant chemoimmunotherapy, which was assessed by independent pathological examination of surgical specimens;
- With or without adjuvant immunotherapy postoperatively;
- Signed and dated written informed consent provided by the patient prior to admission to the study.
Who cannot join
- EGFR or ALK aberrations positive;
- With primary/secondary immunodeficiency diseases or symptomatic interstitial lung diseases;
- With a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of study drug administration;
- With other active malignant tumors currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drugs;
- Receipt of other investigational drugs during the observation period;
- Unable to follow the procedures required in the protocol due to any medical, mental or psychological conditions.
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangya Hospital, Central South University Affiliated
Changsha, Hunan, 410008
About this study
Official title: The Efficacy and Safety of Adjuvant Immunotherapy After Pathological Complete Response Following Neoadjuvant Chemoimmunotherapy in Patients with Resectable NSCLC: a Prospective Real-World Study
This is a prospective, observational, multicenter real-world study aiming to investigate the efficacy and safety of NSCLC patients with or without adjuvant immunotherapy who have achieved pathologic complete remission after neoadjuvant immunotherapy.
- Conditions
- Resectable/Potentially Resectable NSCLC
- Being tested
- Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyDrug
Monotherapy with PD-1 inhibitors, up to 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant immunotherapy | Not described Receives: Drug: Immunotherapy | |
| Observational | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS (Disease-Free Survival)
Evaluated by investigator based on RECIST1.1
Measured: Approximately 3 years
Secondary outcomes (4)
3-year DFS (disease-free survival) rate
Evaluated by investigator based on RECIST1.1
Measured: Approximately 3 years
OS (Overall Survival)
Evaluated by investigator based on RECIST1.1
Measured: Approximately 3 years
Recurrence and Metastasis Pattern
Measured: Approximately 3 years
AE (Adverse Event)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered an investigational product. Safety and tolerance evaluated by incidence, severity and outcomes of AEs (according to NCICTCAE 5.0)
Measured: Approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Jul 2020
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable/Potentially Resectable NSCLCStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243679
- Sponsor's protocol ID
- RWNEOADJ-01
- Status last verified
- Jan 2024
- First submitted
- 29 Jan 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Adjuvant Immunotherapy After Pathological Complete Response Following Neoadjuvant Chemoimmunotherapy in Patients with Resectable NSCLC: a Prospective Real-World Study
- ClinicalTrials.gov ID
- NCT06243679
- Acronym / sponsor ID
- RWNEOADJ-01
- Conditions
- Resectable/Potentially Resectable NSCLC
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 6 Feb 2024 (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.
This is a prospective, observational, multicenter real-world study aiming to investigate the efficacy and safety of NSCLC patients with or without adjuvant immunotherapy who have achieved pathologic complete remission after neoadjuvant immunotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant immunotherapy | – | Drug: Immunotherapy |
| Observational | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with resectable non-small cell lung cancer (NSCLC) who have received immune checkpoint inhibitor neoadjuvant therapy and achieved pathological complete response (pCR).
Key inclusion criteria (8 listed)
- 18 years ≤ age ≤ 80 years;
- Histologically or cytologically confirmed NSCLC;
- Resectable stage IB, II, IIIA, or IIIB (N2) NSCLC according to the staging criteria of the American Joint Committee on Cancer (8th edition);
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 at baseline;
- With measurable or evaluable diseases according to the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) at baseline;
Key exclusion criteria (6 listed)
- EGFR or ALK aberrations positive;
- With primary/secondary immunodeficiency diseases or symptomatic interstitial lung diseases;
- With a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of study drug administration;
- With other active malignant tumors currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drugs;
- Receipt of other investigational drugs during the observation period;
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 |
|---|---|---|
| ImmunotherapyMonotherapy with PD-1 inhibitors, up to 1 year. | Drug | Adjuvant immunotherapy |
Primary outcome
DFS (Disease-Free Survival)
Time frame: Approximately 3 years
Evaluated by investigator based on RECIST1.1
4 secondary outcomes
3-year DFS (disease-free survival) rate
Time frame: Approximately 3 years
OS (Overall Survival)
Time frame: Approximately 3 years
Recurrence and Metastasis Pattern
Time frame: Approximately 3 years
AE (Adverse Event)
Time frame: Approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resectable/Potentially Resectable NSCLC, run by Xiangya Hospital of Central South University 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 8 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 6 Dec 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?
This study is still under way. Results are not available in the source record yet.
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?
DFS (Disease-Free Survival) (time frame: Approximately 3 years). 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 6 Dec 2024.