Non-small Cell Lung Cancer Stage IIIB/IVNCT06310915
Oral Chemotherapeutic Drugs Were Analyzed in Patients With Driver Gene Negative Locally Advanced/Advanced Non-small Cell Lung Cancer With PS Score 2 A Prospective, Single-arm, Multicenter, Observational Study on the Efficacy and Safety of Radiochemotherapy Combined With PD-1 Inhibitor
An observational study of Non-small Cell Lung Cancer Stage IIIB/IV, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
Oral chemotherapeutic drugs were analyzed in patients with driver gene negative locally advanced/advanced non-small cell lung cancer with PS score 2 A prospective, single-arm, multicenter, observational study on the efficacy and safety of radiochemotherapy combined with PD-1 inhibitor. 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 IIIB/IV
- What is being tested?
- Navelbine oral,Pembrolizumab
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2023to May 2025
- Phase
- Observational
- 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
Study population: Patients with PS score 2 for locally advanced/advanced non-small cell lung cancer with negative driver genes
Who may be able to join
- 1. Age of 18-80 years old, both sexes;
- 2. Patients with histologically confirmed advanced non-small cell lung cancer with stage IIIB /IV disease (according to the International Association for the Study of Lung Cancer Staging Manual for Thoracic Tumors, 8th edition) or disease recurrence or progression after multimodal treatment (radiotherapy, surgical resection, or definitive chemoradiotherapy for locally advanced disease);
- 3. Patients should have no EGFR gene sensitive mutations (including but not limited to exon 19 deletion, exon 21 L858R mutation, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation), ALK gene rearrangement, or ROS1;
Who cannot join
- 4.Participants had to have measurable lesions on CT or MRI according to RECIST 1.1 (tumor imaging was performed within 28 days before the first dose of study drug) or clinically significant lesions that could be followed for response according to RECIST 1.1 by the investigator;
- 5. No prior systemic therapy (patients with prior platinum-based adjuvant chemotherapy, neoadjuvant chemotherapy, or definitive chemoradiotherapy for advanced disease could enter if disease progression occurred >6 months after the last treatment);
- 6. Ecog ps =2分;
- 7. Estimated survival time > 12 weeks;
- 1. Subjects requiring systemic treatment with glucocorticoids (>10mg prednisone equivalent daily) or other immunosuppressive drugs within 14 days before the first dose of study drug were excluded. Subjects using inhaled or topical corticosteroids, as well as adrenocortical steroid replacement therapy doses equivalent to >10 mg prednisone/day, were eligible to participate if they did not have active autoimmune disease. In addition, the participants had to have discontinued glucocorticoids or were taking prednisone at a dose of less than 10mg per day (or equivalent) that was stable or reduced.
- 2. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies or any other antibody or agent that targets T-cell costimulation or the immune checkpoint pathway;
Show all 18Show fewer
- 3. Previous treatment with a trial drug;
- 4. Subjects with active CNS metastases were excluded. Participants could participate if CNS metastases could be adequately treated and if their neurologic symptoms (other than residual signs or symptoms related to CNS therapy) returned to baseline at least 2 weeks before enrollment.
- 5. Previous malignant tumor (excluding non-melanoma skin cancer and the following carcinomas in situ: Cancer in situ of the bladder, stomach, colon, endometrium, cervix/dysplasia, melanoma, or breast) were excluded unless they had achieved a complete response at least 2 years before study entry and had not undertaken and did not require additional therapy (other than antiestrogen/androgen therapy or bisphosphonate therapy) during the study. Subjects with other active malignant tumors requiring concurrent treatment were excluded.
- 6. Women with a positive pregnancy test at recruitment or before study dosing;
- 7. Carcinomatous meningitis;
- 8. The subject has a history of interstitial lung disease (e.g., sarcoidosis) that is symptomatic or may preclude the detection or management of suspected drug-related pulmonary toxicity;
- 9. Subjects with COPD can be enrolled in the study if the disease is controlled at the time of enrollment;
- 10. Serious or uncontrolled illness that, in the opinion of the investigator, would increase the risk associated with participation in the study or administration of the study drug, affect the ability of the subject to receive the treatment specified in the protocol, or interfere with the interpretation of the safety results;
- 11. Subjects with active, known, or suspected autoimmune disease. Subjects were eligible if they had type I diabetes, hypothyroidism requiring only hormone replacement therapy, skin conditions that did not require systemic treatment (such as vitiligo, psoriasis, or alopecia), or conditions that were not expected to recist in the absence of external stimuli;
- 12. All toxicities from previous anticancer treatment (except alopecia and fatigue) had to have returned to grade 1 (according to NCI CTCAE, version 4) or baseline before starting the study drug. Subjects were eligible if the toxicity of previous anticancer therapy was not expected to resolve and resulted in long-term sequelae, such as neuropathy after treatment with platinum-based agents
- 13. Subjects must have recovered from major surgery or severe trauma for at least 14 days before the first dose of study treatment;
- 14. Subjects who have received previous cellular immunotherapy such as cytokine-induced killer [CIK] therapy;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangdong, Guangzhou, 510000
zhou chegnzhi, doctor, 13560351186, doctorzcz@163.com
About this study
Official title: This Study is a Pilot Study in Driver-negative Locally Advanced/Late-stage Nonsmall Cell Lung Cancer With ECOG PS=2 Analysing the Efficacy, Safety and Efficacy of Oral Chemotherapy in Combination With PD-1 Inhibitors and Safety of Oral Chemotherapy in Combination With PD-1 Inhibitors in Patients With Locally Advanced/Advanced Non-cellular Lung Cancer withECOG PS=2.This is a Prospective, Single-arm, Multicentre, Observational Study
Oral chemotherapeutic drugs were analyzed in patients with driver gene negative locally advanced/advanced non-small cell lung cancer with PS score 2 A prospective, single-arm, multicenter, observational study on the efficacy and safety of radiochemotherapy combined with PD-1 inhibitor.
- Conditions
- Non-small Cell Lung Cancer Stage IIIB/IV
- Being tested
- Navelbine oral,Pembrolizumab
- Keywords
- Advanced non-small cell lung cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navelbine oral,PembrolizumabDrug
Oral vinorelbine was administered three times weekly, and pembrolizumab was administered every 3 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival time
The time from the date of randomization to the date of first documented disease progression, assessed up to 2 years.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start17 Mar 2023
- Primary completionMar 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage IIIB/IVStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310915
- Sponsor's protocol ID
- CROC202310
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This Study is a Pilot Study in Driver-negative Locally Advanced/Late-stage Nonsmall Cell Lung Cancer With ECOG PS=2 Analysing the Efficacy, Safety and Efficacy of Oral Chemotherapy in Combination With PD-1 Inhibitors and Safety of Oral Chemotherapy in Combination With PD-1 Inhibitors in Patients With Locally Advanced/Advanced Non-cellular Lung Cancer withECOG PS=2.This is a Prospective, Single-arm, Multicentre, Observational Study
- ClinicalTrials.gov ID
- NCT06310915
- Acronym / sponsor ID
- CROC202310
- Conditions
- Non-small Cell Lung Cancer Stage IIIB/IV
- Keywords
- Advanced non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 15 Mar 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.
Oral chemotherapeutic drugs were analyzed in patients with driver gene negative locally advanced/advanced non-small cell lung cancer with PS score 2 A prospective, single-arm, multicenter, observational study on the efficacy and safety of radiochemotherapy combined with PD-1 inhibitor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PS score 2 for locally advanced/advanced non-small cell lung cancer with negative driver genes
Key inclusion criteria (3 listed)
- 1. Age of 18-80 years old, both sexes;
- 2. Patients with histologically confirmed advanced non-small cell lung cancer with stage IIIB /IV disease (according to the International Association for the Study of Lung Cancer Staging Manual for Thoracic Tumors, 8th edition) or disease recurrence or progression after multimodal treatment (radiotherapy, surgical resection, or definitive chemoradiotherapy for locally advanced disease);
- 3. Patients should have no EGFR gene sensitive mutations (including but not limited to exon 19 deletion, exon 21 L858R mutation, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation), ALK gene rearrangement, or ROS1;
Key exclusion criteria (18 listed)
- 4.Participants had to have measurable lesions on CT or MRI according to RECIST 1.1 (tumor imaging was performed within 28 days before the first dose of study drug) or clinically significant lesions that could be followed for response according to RECIST 1.1 by the investigator;
- 5. No prior systemic therapy (patients with prior platinum-based adjuvant chemotherapy, neoadjuvant chemotherapy, or definitive chemoradiotherapy for advanced disease could enter if disease progression occurred >6 months after the last treatment);
- 6. Ecog ps =2分;
- 7. Estimated survival time > 12 weeks;
- 1. Subjects requiring systemic treatment with glucocorticoids (>10mg prednisone equivalent daily) or other immunosuppressive drugs within 14 days before the first dose of study drug were excluded. Subjects using inhaled or topical corticosteroids, as well as adrenocortical steroid replacement therapy doses equivalent to >10 mg prednisone/day, were eligible to participate if they did not have active autoimmune disease. In addition, the participants had to have discontinued glucocorticoids or were taking prednisone at a dose of less than 10mg per day (or equivalent) that was stable or reduced.
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 |
|---|---|---|
| Navelbine oral,PembrolizumabOral vinorelbine was administered three times weekly, and pembrolizumab was administered every 3 weeks | Drug | – |
Primary outcome
Progression-free survival time
Time frame: 2 year
The time from the date of randomization to the date of first documented disease progression, assessed up to 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Related trials for Non-small Cell Lung Cancer Stage IIIB/IV
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 3
Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
Advanced Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
RecruitingPhase 3
Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer
Advanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma
RecruitingPhase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
Advanced Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma
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.
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 Non-small Cell Lung Cancer Stage IIIB/IV, run by Guangzhou Institute of Respiratory Disease 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 3 inclusion and 18 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 15 Mar 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?
Contact zhou chengzhi, doctor (13560351186, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival time (time frame: 2 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 15 Mar 2024.