NSCLCNCT07179445
Analysis of Deoxyribonucleic Acid and Ribonucleic Acid Next-Generation Sequencing in Non-Small Cell Lung Cancer Patients Without Pathological Complete Response Following Neoadjuvant Immunotherapy
An observational study of NSCLC, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This multicenter, retrospective cohort study plans to enroll patients with lung adenocarcinoma who received neoadjuvant immunotherapy prior to surgery and did not achieve pathological complete response (non-pCR) upon postoperative pathological evaluation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Not applicable- observational study
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2025to 31 May 2026
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This multicenter, retrospective cohort study plans to enroll patients with non-small cell lung cancer (NSCLC). Cases meeting the eligibility criteria between January 2022 and December 2024 will first be identified through the hospital pathology information management system. The screening process consists of two stages: Initial Screening: Extraction of data from electronic medical records for patients aged ≥18 years, with pathologically confirmed NSCLC, and who underwent genetic testing prior to surgery. Collection of Neoadjuvant Immunotherapy Information: 1. Received preoperative neoadjuvant immunotherapy, including regimens such as immune monotherapy, immune combination chemotherapy, or immune combination with antiangiogenic agents, with available postoperative pathological assessment results; 2. Exclusion of EGFR and ALK positivity in pre-treatment biopsy samples; 3. Availability of qualifying surgical tissue samples. Estimating a requirement of 300 cases.
Who may be able to join
- Aged 18 years or older, regardless of sex.
- Pathologically confirmed, resectable non-small cell lung cancer (NSCLC); having received neoadjuvant therapy containing immune checkpoint inhibitors prior to surgery; without achieving pathological complete response (non-pCR) upon postoperative pathological assessment.
- Molecular characteristics: Pre-treatment biopsy specimens tested negative for EGFR mutations and ALK fusions by DNA-based NGS or PCR methods.
- Sample requirements: Availability of 5-10 formalin-fixed, paraffin-embedded (FFPE) sections prepared from surgical tissue specimens, with ≥5% tumor cell content confirmed by H\&E staining.
Who cannot join
- Failure to meet any one of the requisite eligibility criteria specified in the inclusion criteria.
- History of a concurrent or prior malignancy at other sites.
- Failure to complete the planned cycles of neoadjuvant immunotherapy due to treatment-related toxicities.
- Any other condition that, in the judgment of the investigator, renders the patient unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University Cancer Institute and Hospital(Lead Center)
Tianjin
Dongsheng Yue Chief Physician of Surgery, +8602223109106, yuedongsheng_cg@163.com
About this study
Official title: A Retrospective Study of Deoxyribonucleic Acid and Ribonucleic Acid Next-Generation Sequencing in Non-Small Cell Lung Cancer Patients With Non-Pathologic Complete Response Following Neoadjuvant Immunotherapy
This multicenter, retrospective cohort study plans to enroll patients with lung adenocarcinoma who received neoadjuvant immunotherapy prior to surgery and did not achieve pathological complete response (non-pCR) upon postoperative pathological evaluation. Using Deoxyribonucleic Acid(DNA) and Ribonucleic Acid(RNA) next-generation sequencing (NGS), the investigators aim to detect driver genetic alterations to investigate the real-world frequency of driver gene positivity in postoperative samples from patients with lung adenocarcinoma-whose EGFR and ALK status had been previously excluded via pathological complete response(pCR) or DNA-based next-generation sequencing-yet still did not attain pathological complete response(pCR) after neoadjuvant immunotherapy. Additionally, the study will characterize the driver-positive patient subgroup and compare the efficacy of postoperative adjuvant immunotherapy between driver-positive and driver-negative populations.
- Conditions
- NSCLC
- Being tested
- Not applicable- observational study
- Keywords
- NSCLC, Neoadjuvant, NGS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Not applicable- observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of driver-alteration-positive patients detected by combined DNA+RNA testing
We selected patients with lung adenocarcinoma who had received preoperative neoadjuvant immunotherapy, did not achieve pathological complete response (pCR) after surgery, and had pre-treatment biopsy samples testing negative for EGFR and ALK alterations. Subsequent combined DNA/RNA next-generation sequencing (NGS) was performed using the 3DMed Onco™ Core Tissue Detection Kit. The proportion of patients with identified driver genomic alterations served as the primary endpoint of the study.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Comparative Analysis of Adjuvant Immunotherapy Efficacy Between Driver-Alteration-Positive and Negative Cohorts
For the comparison between driver gene-positive and negative populations:
Disease-Free Survival (DFS) will be compared between patients who received adjuvant immunotherapy and were driver gene-positive versus those who were driver gene-negative. DFS is defined as the time from surgery to the first occurrence of disease recurrence, distant metastasis, or death from any cause.
Measured: through study completion, an average of 1 year
Stratified Analysis of EGFR/ALK-Positive Versus Other Driver-Alteration-Positive Subgroups
For the stratified analysis among positive populations:
Among the driver gene-positive patients who received adjuvant immunotherapy, a stratified analysis will be performed comparing patients with EGFR or ALK mutations versus those with mutations in other driver genes (e.g., ROS1, BRAF V600E, MET, RET, etc.).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start20 Sep 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongsheng Yue, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179445
- Sponsor's protocol ID
- LUAD-non-pCR-001
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Deoxyribonucleic Acid and Ribonucleic Acid Next-Generation Sequencing in Non-Small Cell Lung Cancer Patients With Non-Pathologic Complete Response Following Neoadjuvant Immunotherapy
- ClinicalTrials.gov ID
- NCT07179445
- Acronym / sponsor ID
- LUAD-non-pCR-001
- Conditions
- NSCLC
- Keywords
- NSCLC, Neoadjuvant, NGS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 17 Sep 2025 (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 multicenter, retrospective cohort study plans to enroll patients with lung adenocarcinoma who received neoadjuvant immunotherapy prior to surgery and did not achieve pathological complete response (non-pCR) upon postoperative pathological evaluation. Using Deoxyribonucleic Acid(DNA) and Ribonucleic Acid(RNA) next-generation sequencing (NGS), the investigators aim to detect driver genetic alterations to investigate the real-world frequency of driver gene positivity in postoperative samples from patients with lung adenocarcinoma-whose EGFR and ALK status had been previously excluded via pathological complete response(pCR) or DNA-based next-generation sequencing-yet still did not attain pathological complete response(pCR) after neoadjuvant immunotherapy. Additionally, the study will characterize the driver-positive patient subgroup and compare the efficacy of postoperative adjuvant immunotherapy between driver-positive and driver-negative populations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This multicenter, retrospective cohort study plans to enroll patients with non-small cell lung cancer (NSCLC). Cases meeting the eligibility criteria between January 2022 and December 2024 will first be identified through the hospital pathology information management system. The screening process consists of two stages: Initial Screening: Extraction of data from electronic medical records for patients aged ≥18 years, with pathologically confirmed NSCLC, and who underwent genetic testing prior to surgery. Collection of Neoadjuvant Immunotherapy Information: 1. Received preoperative neoadjuvant immunotherapy, including regimens such as immune monotherapy, immune combination chemotherapy, or immune combination with antiangiogenic agents, with available postoperative pathological assessment results; 2. Exclusion of EGFR and ALK positivity in pre-treatment biopsy samples; 3. Availability of qualifying surgical tissue samples. Estimating a requirement of 300 cases.
Key inclusion criteria (4 listed)
- Aged 18 years or older, regardless of sex.
- Pathologically confirmed, resectable non-small cell lung cancer (NSCLC); having received neoadjuvant therapy containing immune checkpoint inhibitors prior to surgery; without achieving pathological complete response (non-pCR) upon postoperative pathological assessment.
- Molecular characteristics: Pre-treatment biopsy specimens tested negative for EGFR mutations and ALK fusions by DNA-based NGS or PCR methods.
- Sample requirements: Availability of 5-10 formalin-fixed, paraffin-embedded (FFPE) sections prepared from surgical tissue specimens, with ≥5% tumor cell content confirmed by H\&E staining.
Key exclusion criteria (4 listed)
- Failure to meet any one of the requisite eligibility criteria specified in the inclusion criteria.
- History of a concurrent or prior malignancy at other sites.
- Failure to complete the planned cycles of neoadjuvant immunotherapy due to treatment-related toxicities.
- Any other condition that, in the judgment of the investigator, renders the patient unsuitable for participation in this study.
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 |
|---|---|---|
| Not applicable- observational studyNot applicable- observational study | Other | – |
Primary outcome
Proportion of driver-alteration-positive patients detected by combined DNA+RNA testing
Time frame: through study completion, an average of 1 year
We selected patients with lung adenocarcinoma who had received preoperative neoadjuvant immunotherapy, did not achieve pathological complete response (pCR) after surgery, and had pre-treatment biopsy samples testing negative for EGFR and ALK alterations. Subsequent combined DNA/RNA next-generation sequencing (NGS) was performed using the 3DMed Onco™ Core Tissue Detection Kit. The proportion of patients with identified driver genomic alterations served as the primary endpoint of the study.
2 secondary outcomes
Comparative Analysis of Adjuvant Immunotherapy Efficacy Between Driver-Alteration-Positive and Negative Cohorts
Time frame: through study completion, an average of 1 year
Stratified Analysis of EGFR/ALK-Positive Versus Other Driver-Alteration-Positive Subgroups
Time frame: through study completion, an average of 1 year
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 17 Sep 2025.
- 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.
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 NSCLC, run by Tianjin Medical University Cancer Institute and 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 17 Sep 2025. 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?
Contact Dongsheng Yue Chief Physician of Surgery (+8602223109106, yuedongsheng_cg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of driver-alteration-positive patients detected by combined DNA+RNA testing (time frame: through study completion, an average of 1 year). 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 17 Sep 2025.