Carcinoma, Non-Small-Cell LungPhase 2NCT05940532
A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC
A Phase 2 study testing Sugemalimab and Chemotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Hunan Cancer Hospital at 1 site in China.
Trial summary
The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Sugemalimab and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2023to Dec 2026
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.18 to 75 years old, both male and female;
- 2.ECOG score: 0-1;
- 3.Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer;
- 4.Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy;
- 5.Measurable lesions available;
- 6.Major organ function is basically normal;
- 7.Estimated survival time is at least 6 months;
- 8.Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before inclusion.
Who cannot join
- Histologically or cytologically confirmed mixed SCLC and NSCLC;
- Subjects with driver gene mutations(EGFR mutation, ALK fusion, etc.);
- Previous systemic anti-tumor therapy including immune checkpoint inhibitors for NSCLC;
- Previous thoracic radiotherapy;
- Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose;
- Systemic immunostimulant therapy before the first dose;
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- Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment;
- Subjects with autoimmune diseases;
- Other malignant tumors other than non-small cell lung cancer within 5 years before screening;
- Known or suspected interstitial pneumonia;
- Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function;
- Severe cardiovascular and cerebrovascular diseases;
- Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose;
- Arteriovenous thrombotic events within 3 months before the first dose;
- Positive HIV test;
- Active hepatitis B or C;
- Evidence of active tuberculosis infection within 1 year before the first dose;
- Serious infection within 4 weeks before the first dose;
- History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study;
- Major surgeries other than diagnosis or biopsy within 28 days prior to the first dose;
- Previous or planned allogeneic bone marrow transplantation or solid organ transplantation;
- History of severe allergic reactions to other monoclonal antibodies/fusion proteins;
- Allergic to any component of the randomized treatment regimen;
- Female subjects who are pregnant, lactating, or planning to get pregnant during the study period;
- Subjects who have a known history of psychotropic drug abuse, alcoholism, or drug abuse;
- Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.
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
Huai Liu, MD, +8619918909231, liuhuai@hnca.org.cn
About this study
Official title: A Single-arm Phase 2 Study of Sugemalimab and Chemotherapy as Induction Therapy in Unresectable and Stage III Non-small Cell Lung Cancer (NSCLC)
The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Sugemalimab and Chemotherapy
- Keywords
- immunotherapy, chemotherapy, radiotherapy, surgery, non-small cell lung cancer
- 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.
Sugemalimab and ChemotherapyDrug
Chemotherapy: Paclitaxel 175mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for NSCLC; Pemetrexed 500mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for non-squamous NSCLC; intravenous infusion every 3 weeks, for up to four cycles.
Sugemalimab: 1200 mg by intravenous infusion every 3 weeks, for up to 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Patients will receive 3 cycles of induction therapy with sugemalimab and chemotherapy before curative local therapy. Receives: Drug: Sugemalimab and Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate
Measured: From the initiation of the first dose to 3 years
Secondary outcomes (7)
PFS
Progression-free survival
Measured: From the initiation of the first dose to 3 years
OS
Overall survival
Measured: From the initiation of the first dose to 3 years
iORR
Objective response rate after induction therapy
Measured: From the initiation of the first dose to 3 years
AEs
Adverse events
Measured: From the initiation of the first dose to 90 days after the last dose
Measurement of Quality of Life with EORTC QLQ-C30 questionnaire
EORTC QLQ-C30 questionnaire minimum value: not at all (1); maximum: very much (4); higher scores means a worse outcome
Measured: From the initiation of the first dose to 3 years
Measurement of Quality of Life with EORTC QLQ-LC13 questionnaire
EORTC QLQ-LC13 questionnaire minimum value: not at all (1); maximum: very much (4); higher scores means a worse outcome
Measured: From the initiation of the first dose to 3 years
Measurement of Quality of Life with EORTC EQ-5D-5L VAS questionnaire
The EQ-5D-5L VAS records the respondent's self-rated health on a 10 centimeter (cm) vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine"
Measured: From the initiation of the first dose to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start14 Jun 2023
- Primary completionJan 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Wang, MD, Principal investigator, the Department of Radiation OncologyHuai Liu, MD, Principal investigator, the Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940532
- Sponsor's protocol ID
- HTOSG Lung 001
- Status last verified
- Jun 2023
- First submitted
- 26 Jun 2023
- Last updated
- 11 Jul 2023
- 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 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Phase 2 Study of Sugemalimab and Chemotherapy as Induction Therapy in Unresectable and Stage III Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT05940532
- Acronym / sponsor ID
- HTOSG Lung 001
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- immunotherapy, chemotherapy, radiotherapy, surgery, non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jul 2023 (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 goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Drug: Sugemalimab and ChemotherapyPatients will receive 3 cycles of induction therapy with sugemalimab and chemotherapy before curative local therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1.18 to 75 years old, both male and female;
- 2.ECOG score: 0-1;
- 3.Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer;
- 4.Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy;
- 5.Measurable lesions available;
Key exclusion criteria (26 listed)
- Histologically or cytologically confirmed mixed SCLC and NSCLC;
- Subjects with driver gene mutations(EGFR mutation, ALK fusion, etc.);
- Previous systemic anti-tumor therapy including immune checkpoint inhibitors for NSCLC;
- Previous thoracic radiotherapy;
- Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before 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 |
|---|---|---|
| Sugemalimab and ChemotherapyChemotherapy: Paclitaxel 175mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for NSCLC; Pemetrexed 500mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for non-squamous NSCLC; intravenous infusion every 3 weeks, for up to four cycles. Sugemalimab: 1200 mg by intravenous infusion every 3 weeks, for up to 2 years. | Drug | Interventional arm |
Primary outcome
ORR
Time frame: From the initiation of the first dose to 3 years
Objective response rate
7 secondary outcomes
PFS
Time frame: From the initiation of the first dose to 3 years
OS
Time frame: From the initiation of the first dose to 3 years
iORR
Time frame: From the initiation of the first dose to 3 years
AEs
Time frame: From the initiation of the first dose to 90 days after the last dose
Measurement of Quality of Life with EORTC QLQ-C30 questionnaire
Time frame: From the initiation of the first dose to 3 years
Measurement of Quality of Life with EORTC QLQ-LC13 questionnaire
Time frame: From the initiation of the first dose to 3 years
Measurement of Quality of Life with EORTC EQ-5D-5L VAS questionnaire
Time frame: From the initiation of the first dose to 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 11 Jul 2023.
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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.
Hui Wang, MD principal investigator
the Department of Radiation Oncology
Huai Liu, MD principal investigator
the Department of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sugemalimab and Chemotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Hunan Cancer 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 8 inclusion and 26 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 11 Jul 2023. 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.
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?
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 Huai Liu, MD (+8619918909231, liuhuai@hnca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: From the initiation of the first dose to 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 11 Jul 2023.