Non-small Cell Lung CancerPhase 2NCT04144582
Sintilimab Combined With Docetaxel for Standard Chemotherapy Failure Non-driver Gene Mutation Metastatic Non-small Cell Lung Cancer
A Phase 2 study testing Sintilimab Combined With Docetaxel Monotherapy in people with Non-small Cell Lung Cancer, run by Yongchang Zhang at 2 sites in China.
Trial summary
The purpose of this study is to assess the safety and effectiveness of Sintilimab Combined With Docetaxel in Non-driver Gene Mutation NSCLC patients who failed with double platinum-based chemotherapy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Sintilimab Combined With Docetaxel Monotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2019to 31 Dec 2021
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Life expectancy exceeds 3 months
- The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard.
Who cannot join
- small cell lung cancer or small cell lung cancer
- Currently involved in interventional clinical research or treatment, or have received other research drugs or used research equipment within 4 weeks prior to the first dose;
- Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (eg, CTLA-4, OX-40, CD137);
Trial locations and contacts
2 sites in 1 country.
China2 sites
Hunan Provincal Tumor Hospital
Changsha, Hunan, 410013
Yongchang Z MD
Changsha, Hunan, 410013
About this study
Official title: Multiple-center, Single-arm, Phase II Study on Sintilimab Combined With Docetaxel in Non-driver Gene Mutation Advanced NSCLC Patients Who Had Failed With Double Platinum-based Chemotherapy
The purpose of this study is to assess the safety and effectiveness of Sintilimab Combined With Docetaxel in Non-driver Gene Mutation NSCLC patients who failed with double platinum-based chemotherapy
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Sintilimab Combined With Docetaxel Monotherapy
- 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.
Sintilimab Combined With Docetaxel MonotherapyDrug
Sintilimab 200mg i.v q3w , Docetaxel 75mg/m2 i.v q3w
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab Combined With Docetaxel | Experimental | Sintilimab Combined With Docetaxel for Metastatic or Non-driver Gene Mutation Non-small Cell Lung Cancer Receives: Drug: Sintilimab Combined With Docetaxel Monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
To measure the patients's overall response rate
Measured: Approximately 1 years
Secondary outcomes (2)
PFS
Progression free survival
Measured: Approximately 1 years
OS
Overall survival
Measured: Approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Jan 2019
- Primary completion30 Sep 2020
- Study completion31 Dec 2021
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 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yongchang Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongchang Zhang, Hunan Province Tumor Hospital
- Investigators
- Yongchang Z MD, MD, Principal investigator, Hunan Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144582
- Sponsor's protocol ID
- STORM
- Status last verified
- Mar 2022
- First submitted
- 28 Oct 2019
- Last updated
- 2 Mar 2022
- 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 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-center, Single-arm, Phase II Study on Sintilimab Combined With Docetaxel in Non-driver Gene Mutation Advanced NSCLC Patients Who Had Failed With Double Platinum-based Chemotherapy
- ClinicalTrials.gov ID
- NCT04144582
- Acronym / sponsor ID
- STORM
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yongchang ZhangUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 Oct 2019 (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.
The purpose of this study is to assess the safety and effectiveness of Sintilimab Combined With Docetaxel in Non-driver Gene Mutation NSCLC patients who failed with double platinum-based chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Sintilimab Combined With Docetaxel | Experimental | Drug: Sintilimab Combined With Docetaxel MonotherapySintilimab Combined With Docetaxel for Metastatic or Non-driver Gene Mutation Non-small Cell Lung Cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Life expectancy exceeds 3 months
- The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard.
Key exclusion criteria (3 listed)
- small cell lung cancer or small cell lung cancer
- Currently involved in interventional clinical research or treatment, or have received other research drugs or used research equipment within 4 weeks prior to the first dose;
- Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (eg, CTLA-4, OX-40, CD137);
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 |
|---|---|---|
| Sintilimab Combined With Docetaxel MonotherapySintilimab 200mg i.v q3w , Docetaxel 75mg/m2 i.v q3w | Drug | Sintilimab Combined With Docetaxel |
Primary outcome
ORR
Time frame: Approximately 1 years
To measure the patients's overall response rate
2 secondary outcomes
PFS
Time frame: Approximately 1 years
OS
Time frame: Approximately 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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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.
Yongchang Z MD, MD principal investigator
Hunan Province Tumor Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab Combined With Docetaxel Monotherapy in people with Non-small Cell Lung Cancer, run by Yongchang Zhang at 2 sites 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ORR (time frame: Approximately 1 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 2 Mar 2022.