SCLC, Extensive StagePhase 2NCT05299255
Utidelone in Third-line and Above Treatment of Small Cell Lung Cancer
A Phase 2 study testing Utidelone in people with SCLC, Extensive Stage, run by Henan Cancer Hospital at 1 site in China.
Trial summary
SCLC has a very high degree of malignancy, and 60% to 70% of patients are diagnosed as extensive stage. The median survival of patients with limited-stage disease is about 15-20 months, and the median OS of patients with extensive-stage disease is about 8-13 months, and the 2-year and 5-year survival rates are about… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SCLC, Extensive Stage
- What is being tested?
- Utidelone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2021to 5 Sep 2023
- 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
- Histologically diagnosed small cell lung cancer (except for small cell lung cancer mixed with other pathological types);
- The expected survival period is not less than 3 months;
- Second-line therapy (excluding maintenance therapy) and above with disease progression or recurrence of small cell lung cancer;
- Patients who have not received chemotherapy, radiotherapy, surgery, targeted therapy and immunotherapy within 4 weeks before enrollment;
- Age 18-75 years old, physical condition score ECOG 0-1 points;
- At least one target lesion measurable by imaging within 3 weeks before enrollment, ordinary CT scan ≥ 20 mm, spiral CT scan diameter ≥ 10 mm (lymph node short diameter ≥ 15 mm);
Show all 12Show fewer
- Asymptomatic brain metastases, or patients with stable disease for more than 4 weeks after brain metastases treatment;
- Neurological lesions should be less than grade 2 within 4 weeks before enrollment (NCI CTC4.03);
- Routine blood and blood biochemical tests were basically normal within 1 week before enrollment (based on the normal value of the research center laboratory, no blood transfusion within 14 days before screening, and no rhG-CSF was used):
- Blood routine: HGB≥9g/dL; ANC≥1.5×109/L; PLT≥80×109/L; Blood biochemistry (without ALB infusion within 14 days): bilirubin <1.5 times the upper limit of normal, ALT and AST ≤2.5 times the upper limit of normal (if liver metastases exist, bilirubin ≤3 times the upper limit of normal, ALT and AST≤3 times the upper limit of normal) 5 times the upper limit of normal), serum Cr≤1.5 times the upper limit of normal or endogenous creatinine clearance ≥45 mL/min (Cockcroft-Gault formula);
- Those who have no major organ dysfunction and no concomitant heart disease;
- Females of childbearing age, including those who are in menopause but have not reached postmenopausal state (natural amenorrhea for 12 consecutive months) and who have not received sterilization and ovarian and/or hysterectomy, must have a blood pregnancy test within 7 days before the first
Who cannot join
- Pregnancy (positive pregnancy test) or lactating patients;
- Patients with active pulmonary tuberculosis;
- Patients with high suspicion of interstitial lung disease;
- Cancerous meningitis patients;
- patients with symptomatic central nervous system (CNS) metastasis;
- Other active malignant tumors that require concurrent treatment, but not including carcinoma in situ of the cervix or basal cell carcinoma of the skin;
Show all 9Show fewer
- Patients with serious diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection, active peptic ulcer, and those with a history of mental illness that is not easy to control;
- HIV positive test results, untreated active hepatitis patients;
- Patients with poor compliance; The investigators believe that those who are not suitable to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Tumor Hospital
Zhengzhou, Henan, 450000
Yanqiu Zhao, MS, 13938252350 ext. 0086, 13938252350@163.com
Baoxia He, MS, 0371-65587418 ext. 0086, hnszlyygcp@163.com
About this study
Official title: An Open, Single-center Phase II Clinical Study of Utidelone in Third-line and Above Treatment of Small Cell Lung Cancer
SCLC has a very high degree of malignancy, and 60% to 70% of patients are diagnosed as extensive stage. The median survival of patients with limited-stage disease is about 15-20 months, and the median OS of patients with extensive-stage disease is about 8-13 months, and the 2-year and 5-year survival rates are about 5% and 1-2%, respectively. However, although the initial treatment has a high effective rate, most patients relapse or progress within 1 year, and the effect of re-treatment is poor and the prognosis is poor. The effective rate of SCLC second-line treatment is only 10-25%, and the median survival time is less than 6 months. After the third and fourth lines, there are almost no recognized treatment options. Therefore, improving the second-line treatment of SCLC has always been a difficult clinical problem, and new drugs are urgently needed to be explored. In small cell lung cancer, based on phase II clinical trials, paclitaxel is currently recommended by NCCN guidelines for subsequent systemic therapy in patients who relapse 6 months or less after initial therapy. Utidelone (UTD1) is an epothilone derivative with a similar mechanism of action to taxanes, but a completely different molecular structure.
Read the detailed description
Compared with paclitaxel, epothilones has higher water solubility and toxicity tolerance, and fewer side effects, these findings suggest that utidron may have better antitumor activity against small cell lung cancer. Therefore, to prospectively observe the treatment of extensive-stage small cell lung cancer with failure of second-line or above chemotherapy and receive Utilidron, so as to understand the efficacy, safety and tolerability of Utilidron in the third-line and above treatment of small cell lung cancer, which is a small Post-line treatment of cell lung cancer provides new directions and treatment options.
This study is an open, single-center phase II clinical study. Small cell lung cancer patients with disease progression or recurrence after second-line therapy or above, receive Utilidron injection. Utilidron injection 40mg/m2/d d1-5 q3w was administered until disease progression (PD), intolerable toxicity, initiation of new antitumor therapy, loss to follow-up, death, and the investigator decided to be tested Subjects who withdraw from the study treatment or the subject/their legal representative requests to withdraw from the study (whichever occurs first). After consultation with the sponsor, the patient will determine whether the treatment can be continued, observe and evaluate the preliminary efficacy and safety.
- Conditions
- SCLC, Extensive Stage
- Being tested
- Utidelone, Placebo
- Keywords
- small cell lung cancer,Utidelone
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UtideloneDrug
Utidelone Versus placebo in Third-line and above treatment of Extensive Small-cell Lung Cancer
PlaceboDrug
the placebo as control group.
| Study group | Role | What they receive |
|---|---|---|
| Utidelone vs placebo | Experimental | Drug: Utidelone vs placebo in Third-line and above Treatment Extensive Small-cell Lung Cancer Receives: Drug: Utidelone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective response rate (ORR) according to the RECIST 1.1
the objective response rate (ORR）of utidelone in the third-Line and above treatment of ES-SCLC
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start5 Sep 2021
- Primary completion5 Sep 2022 (estimated)
- Study completion5 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC, Extensive StageStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yanqiu Zhao, Henan Cancer Hospital
- Investigators
- Yanqiu Zhao, MS, Principal investigator, Henan Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299255
- Sponsor's protocol ID
- HXNI-YTDL-001
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-center Phase II Clinical Study of Utidelone in Third-line and Above Treatment of Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05299255
- Acronym / sponsor ID
- HXNI-YTDL-001
- Conditions
- SCLC, Extensive Stage
- Keywords
- small cell lung cancer,Utidelone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 5 Sep 2021 (actual)
- Primary completion
- 5 Sep 2022 (estimated)
- Study completion
- 5 Sep 2023 (estimated)
- First posted
- 28 Mar 2022 (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.
SCLC has a very high degree of malignancy, and 60% to 70% of patients are diagnosed as extensive stage. The median survival of patients with limited-stage disease is about 15-20 months, and the median OS of patients with extensive-stage disease is about 8-13 months, and the 2-year and 5-year survival rates are about 5% and 1-2%, respectively. However, although the initial treatment has a high effective rate, most patients relapse or progress within 1 year, and the effect of re-treatment is poor and the prognosis is poor. The effective rate of SCLC second-line treatment is only 10-25%, and the median survival time is less than 6 months. After the third and fourth lines, there are almost no recognized treatment options. Therefore, improving the second-line treatment of SCLC has always been a difficult clinical problem, and new drugs are urgently needed to be explored. In small cell lung cancer, based on phase II clinical trials, paclitaxel is currently recommended by NCCN guidelines for subsequent systemic therapy in patients who relapse 6 months or less after initial therapy. Utidelone (UTD1) is an epothilone derivative with a similar mechanism of action to taxanes, but a completely different molecular structure.
Detailed description
Compared with paclitaxel, epothilones has higher water solubility and toxicity tolerance, and fewer side effects, these findings suggest that utidron may have better antitumor activity against small cell lung cancer. Therefore, to prospectively observe the treatment of extensive-stage small cell lung cancer with failure of second-line or above chemotherapy and receive Utilidron, so as to understand the efficacy, safety and tolerability of Utilidron in the third-line and above treatment of small cell lung cancer, which is a small Post-line treatment of cell lung cancer provides new directions and treatment options.
This study is an open, single-center phase II clinical study. Small cell lung cancer patients with disease progression or recurrence after second-line therapy or above, receive Utilidron injection. Utilidron injection 40mg/m2/d d1-5 q3w was administered until disease progression (PD), intolerable toxicity, initiation of new antitumor therapy, loss to follow-up, death, and the investigator decided to be tested Subjects who withdraw from the study treatment or the subject/their legal representative requests to withdraw from the study (whichever occurs first). After consultation with the sponsor, the patient will determine whether the treatment can be continued, observe and evaluate the preliminary efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Utidelone vs placebo | Experimental | Drug: Utidelone, Drug: PlaceboDrug: Utidelone vs placebo in Third-line and above Treatment Extensive 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 (12 listed)
- Histologically diagnosed small cell lung cancer (except for small cell lung cancer mixed with other pathological types);
- The expected survival period is not less than 3 months;
- Second-line therapy (excluding maintenance therapy) and above with disease progression or recurrence of small cell lung cancer;
- Patients who have not received chemotherapy, radiotherapy, surgery, targeted therapy and immunotherapy within 4 weeks before enrollment;
- Age 18-75 years old, physical condition score ECOG 0-1 points;
Key exclusion criteria (9 listed)
- Pregnancy (positive pregnancy test) or lactating patients;
- Patients with active pulmonary tuberculosis;
- Patients with high suspicion of interstitial lung disease;
- HIV positive test results, untreated active hepatitis patients;
- Patients with poor compliance; The investigators believe that those who are not suitable to participate in this trial.
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 |
|---|---|---|
| UtideloneUtidelone Versus placebo in Third-line and above treatment of Extensive Small-cell Lung Cancer | Drug | Utidelone vs placebo |
| Placebothe placebo as control group. | Drug | Utidelone vs placebo |
Primary outcome
The objective response rate (ORR) according to the RECIST 1.1
Time frame: 24 weeks
the objective response rate (ORR）of utidelone in the third-Line and above treatment of ES-SCLC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
Related trials for SCLC, Extensive Stage
Active, not recruitingPhase 3
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Extensive-Stage Small-Cell Lung Cancer, Small-Cell Lung Cancer
RecruitingPhase 2
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Extensive-stage Small-cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
RecruitingPhase 2
MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Small Cell Lung Cancer, SCLC
Not yet recruitingPhase 2
Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage
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.
Yanqiu Zhao, MS principal investigator
Henan Tumor Hospital
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 Utidelone in people with SCLC, Extensive Stage, run by Henan 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 12 inclusion and 9 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 28 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanqiu Zhao, MS (13938252350 ext. 0086, 13938252350@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The objective response rate (ORR) according to the RECIST 1.1 (time frame: 24 weeks). 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 28 Mar 2022.