Lung CancerSoulNCT03647098
Survival Outcomes of Lung Cancer
An observational study of Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
This is a prospective study to analyze the survival outcomes of different groups about lung cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Treatment
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 31 Dec 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: lung cancer
Who may be able to join
- Understand the requirements and contents of the clinical trial .
- Age ≥ 18 years.
- Histopathology or cytology confirmed lung cancer
- ECOG <=2.
- Predicted survival ≥ 12 weeks.
- Adequate bone marrow hematopoiesis and organ function
- Presence of measurable lesions according to RECIST 1.1.
Who cannot join
- Subjects who have received any of the following treatments must be excluded:
- Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.
- Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose.
- Presence of spinal cord compression or meningeal metastasis.
- History of other malignant tumors within 2 years.
- Adverse events (except alopecia of any degree) of CTCAE > grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
Show all 16Show fewer
- History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
- The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
- Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
- Heart-related diseases or abnormalities
- Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
- Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb drugs due to previous bowel resection.
- Live vaccine was given 2 weeks before the first medication.
- Women who are breastfeeding or pregnant.
- Hypersensitivity to the test drug and the ingredients.
- Other conditions assessed by the investigator to be unsuitable for participation in the 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, 1 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Nong Yang, MD, +86 731 89762323, yangnong0217@163.com
Yongchang Zhang, MD, +86 731 89762321, zhangyongchang@csu.edu.cn
About this study
Official title: Survival Outcomes for Lung Cancer
This is a prospective study to analyze the survival outcomes of different groups about lung cancer patients.
Read the detailed description
This study aims to analyze the survival outcomes of different groups about lung cancer patients. All the groups were assessed to the treatment decisions guided by molecular profiling and clinical judgment of principal investigators
- Conditions
- Lung Cancer
- Being tested
- Treatment
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentDrug
Treatment decisions guided by molecular profiling and clinical judgment of principal investigators
| Study group | Role | What they receive |
|---|---|---|
| Cohorts 1 | Non-small cell lung cancer patients with EGFR mutations. Group A ： Single EGFR Drive gene Mutations Group B ：EGFR co-mutant with De novo MET alterations Group C ：EGFR co-mutant with other genes including ALK , ROS , RET , BRAF .etc Receives: Drug: Treatment | |
| Cohorts 2 | Non-small cell lung cancer patients with ALK-fusion positive. Receives: Drug: Treatment | |
| Cohorts 3 | Non-small cell lung cancer patients with ROS-1-positive. Receives: Drug: Treatment | |
| Cohorts 4 | Non-small cell lung cancer patients with Other Rare Mutations. Receives: Drug: Treatment | |
| Cohorts 5 | Driver-negative lung cancer patients with ADC and SQC. Receives: Drug: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS defines as first dose to first documented disease progression assessed by investigator or death due to any cause.
Measured: Time from first subject dose to study completion, or up to 5 years
Secondary outcomes (2)
Overall survival (OS)
To assess overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)
Measured: Time from first subject dose to study completion, or up to 5 years
Adverse events (AEs)
Number of participants with adverse events (AEs) according to CTCAE 5.0
Measured: Time from first subject dose to study completion, or up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Aug 2018
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
- Investigators
- Yongchang Zhang, MD, Principal investigator, zhangyongchang@csu.edu.cn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647098
- Sponsor's protocol ID
- 20180176
- Acronym
- Soul
- Status last verified
- Feb 2025
- First submitted
- 23 Aug 2018
- Last updated
- 14 Feb 2025
- 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 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Outcomes for Lung Cancer
- ClinicalTrials.gov ID
- NCT03647098
- Acronym / sponsor ID
- Soul / 20180176
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Aug 2018 (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 study to analyze the survival outcomes of different groups about lung cancer patients.
Detailed description
This study aims to analyze the survival outcomes of different groups about lung cancer patients. All the groups were assessed to the treatment decisions guided by molecular profiling and clinical judgment of principal investigators
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohorts 1 | – | Drug: TreatmentNon-small cell lung cancer patients with EGFR mutations. Group A ： Single EGFR Drive gene Mutations Group B ：EGFR co-mutant with De novo MET alterations Group C ：EGFR co-mutant with other genes including ALK , ROS , RET , BRAF .etc |
| Cohorts 2 | – | Drug: TreatmentNon-small cell lung cancer patients with ALK-fusion positive. |
| Cohorts 3 | – | Drug: TreatmentNon-small cell lung cancer patients with ROS-1-positive. |
| Cohorts 4 | – | Drug: TreatmentNon-small cell lung cancer patients with Other Rare Mutations. |
| Cohorts 5 | – | Drug: TreatmentDriver-negative lung cancer patients with ADC and SQC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- lung cancer
Key inclusion criteria (7 listed)
- Understand the requirements and contents of the clinical trial .
- Age ≥ 18 years.
- Histopathology or cytology confirmed lung cancer
- ECOG <=2.
- Predicted survival ≥ 12 weeks.
Key exclusion criteria (16 listed)
- Subjects who have received any of the following treatments must be excluded:
- Presence of spinal cord compression or meningeal metastasis.
- History of other malignant tumors within 2 years.
- Adverse events (except alopecia of any degree) of CTCAE > grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
- History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
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 |
|---|---|---|
| TreatmentTreatment decisions guided by molecular profiling and clinical judgment of principal investigators | Drug | Cohorts 1, Cohorts 2, Cohorts 3, Cohorts 4, Cohorts 5 |
Primary outcome
Progression-free survival (PFS)
Time frame: Time from first subject dose to study completion, or up to 5 years
PFS defines as first dose to first documented disease progression assessed by investigator or death due to any cause.
2 secondary outcomes
Overall survival (OS)
Time frame: Time from first subject dose to study completion, or up to 5 years
Adverse events (AEs)
Time frame: Time from first subject dose to study completion, or up to 5 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 14 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
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
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
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)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Yongchang Zhang, MD principal investigator
zhangyongchang@csu.edu.cn
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 Lung Cancer, run by Hunan Province Tumor 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 7 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 14 Feb 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 Yongchang Zhang, MD (+8613873123436 ext. +8613873123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Time from first subject dose to study completion, or up to 5 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 14 Feb 2025.