Small-cell Lung CancerPhase 2NCT03613753
Irinotecan Plus Lobaplatin Versus Irinotecan in the Second-line Treatment of Small Cell Lung Cancer
A Phase 2 study testing irinotecan plus lobaplatin and irinotecan in people with Small-cell Lung Cancer, run by ShengFa Su at 1 site in China.
Trial summary
This randomized phase II study compare survival outcomes and toxicity of two chemotherapy regimens (irinotecan plus lobaplatin or irinotecan) for the second-line treatment of recurrent small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Small-cell Lung Cancer
- What is being tested?
- irinotecan plus lobaplatin and irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 1 Jun 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed SCLC
- Etoposide with cisplatin or carboplatin was first-line chemotherapy in SCLC
- At least 30 days after the completion of first-line chemotherapy
- Either sex, age between 18 to 70 years
- Expected life time ≥ 3 months
- Performance status ECOG grade 0-1. Patients with PS 2 whose general condition is explained by obstructive/bulky disease likely to improve after the first cycle of chemotherapy can be included at the discretion of the local investigator. Patients with PS 2 as a result of comorbid conditions will be excluded.
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- Adequate bone marrow and organ function as defined below:
- Neutrophils ≥ 1.5 × 109/L, platelets 80 × 109/L, hemoglobin ≥80 g/L; AST and ALT ≤2× the upper limit of the institutional normal range, total bilirubin ≤1.25× the upper limit of the institutional normal range; Creatinineconcentration ≤120 μmol/L
- Had measurable or assessable disease
Who cannot join
- Concomitant with other malignant disease
- Pregnancy or lactation at the time of enrollment
- Any contraindications for chemotherapy
- Received target therapy or immunotherapy
Trial locations and contacts
1 site in 1 country.
Bing Lu, MD contact
China1 site, 1 recruiting
- Recruiting
The affiliated hospital of Guizhou medical university
Guiyang, Guizhou, 550004
Shengfa Su, PhD,MD, 86-13608550432, sushengfa2005@163.com
About this study
Official title: A Randomized Phase II Trial of Irinotecan Plus Lobaplatin Versus Irinotecan for the Second-line Treatment of Relapsed Small-cell Lung Cancer
This randomized phase II study compare survival outcomes and toxicity of two chemotherapy regimens (irinotecan plus lobaplatin or irinotecan) for the second-line treatment of recurrent small-cell lung cancer.
Read the detailed description
The most widely applied first-line treatment mode for small-cell lung cancer (SCLC) patients was chemotherapy as initial treatment. Etoposide with cisplatin or carboplatin were considered the standard first-line regimen in SCLC. As for second-line chemotherapy, single regimen irinotecan or a combined regimen containing irinotecan were one of preferred regiems. While there still is no consensus on second-line therapy. Clinical studies have demonstrated that the combination of irinotecan and carboplatin or cisplatin did not improve outcome in recurrent SCLC patients compared with irinotecan alone. One of the main reasons is that carboplatin or cisplatin has been used in the first-line treatment, and SCLC showed cross-resistance to carboplatin and cisplatin.
Lobaplatin is a platinum complex with DNA alkylating activity that was developed by ASTA Medica (Degussa) for the treatment of cancer. Lobaplatin as the third-generation platinum antineoplastic agent, showed promising antineoplastic effects in variety of preclinical test tumor models, which overcomes some forms of cisplatin or carboplatin resistance in preclinical tumour models. Retrospective studies also have demonstrated the efficacy of Lobaplatin in patients with relapsed SCLC. Thus, we perform this randomized study to compare the efficacy and safety of irinotecan plus lobaplatin versus irinotecan in patients recurrent SCLC.
- Conditions
- Small-cell Lung Cancer
- Being tested
- irinotecan plus lobaplatin, irinotecan
- Keywords
- relapsed
- Medical subject headings
- Small Cell Lung Carcinoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irinotecan plus lobaplatinDrug
irinotecan plus lobaplatin chemotherapy
irinotecanDrug
irinotecan chemotherapy alone
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Chemotherapy:irinotecan plus lobaplatin Receives: Drug: irinotecan plus lobaplatin |
| Arm B | Active comparator | Chemotherapy:irinotecan Receives: Drug: irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Tumor Response will be evaluated using the RECIST 1.1 criteria.ORR is Partial response (PR) and complete response (CR).
Measured: >4 weeks post treatment
Secondary outcomes (3)
Treatment toxicities
To assess and record nausea, vomiting, hematologic toxicity,and other treantment complications by CTCAE v4.0
Measured: up to 12 months
Progression-free survival(PFS)
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Measured: up to 12 months
Overall survival(OS)
Overall survival is defined as the time interval from date of diagnosis to date of death from any cause
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Jun 2018
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShengFa Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ShengFa Su, Guizhou Medical University
- Investigators
- ShengFa Su, PhD,MD, Principal investigator, The Affiliated Hospital Of Guizhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613753
- Sponsor's protocol ID
- R-SCLC-001
- Status last verified
- Feb 2020
- First submitted
- 21 Jul 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Irinotecan Plus Lobaplatin Versus Irinotecan for the Second-line Treatment of Relapsed Small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03613753
- Acronym / sponsor ID
- R-SCLC-001
- Conditions
- Small-cell Lung Cancer
- Keywords
- relapsed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- ShengFa SuUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 3 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 randomized phase II study compare survival outcomes and toxicity of two chemotherapy regimens (irinotecan plus lobaplatin or irinotecan) for the second-line treatment of recurrent small-cell lung cancer.
Detailed description
The most widely applied first-line treatment mode for small-cell lung cancer (SCLC) patients was chemotherapy as initial treatment. Etoposide with cisplatin or carboplatin were considered the standard first-line regimen in SCLC. As for second-line chemotherapy, single regimen irinotecan or a combined regimen containing irinotecan were one of preferred regiems. While there still is no consensus on second-line therapy. Clinical studies have demonstrated that the combination of irinotecan and carboplatin or cisplatin did not improve outcome in recurrent SCLC patients compared with irinotecan alone. One of the main reasons is that carboplatin or cisplatin has been used in the first-line treatment, and SCLC showed cross-resistance to carboplatin and cisplatin.
Lobaplatin is a platinum complex with DNA alkylating activity that was developed by ASTA Medica (Degussa) for the treatment of cancer. Lobaplatin as the third-generation platinum antineoplastic agent, showed promising antineoplastic effects in variety of preclinical test tumor models, which overcomes some forms of cisplatin or carboplatin resistance in preclinical tumour models. Retrospective studies also have demonstrated the efficacy of Lobaplatin in patients with relapsed SCLC. Thus, we perform this randomized study to compare the efficacy and safety of irinotecan plus lobaplatin versus irinotecan in patients recurrent SCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: irinotecan plus lobaplatinChemotherapy:irinotecan plus lobaplatin |
| Arm B | Active comparator | Drug: irinotecanChemotherapy:irinotecan |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Relapsed SCLC
- Etoposide with cisplatin or carboplatin was first-line chemotherapy in SCLC
- At least 30 days after the completion of first-line chemotherapy
- Either sex, age between 18 to 70 years
- Expected life time ≥ 3 months
Key exclusion criteria (4 listed)
- Concomitant with other malignant disease
- Pregnancy or lactation at the time of enrollment
- Any contraindications for chemotherapy
- Received target therapy or immunotherapy
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 |
|---|---|---|
| irinotecan plus lobaplatinirinotecan plus lobaplatin chemotherapy | Drug | Arm A |
| irinotecanirinotecan chemotherapy alone | Drug | Arm B |
Primary outcome
Objective Response Rate (ORR)
Time frame: >4 weeks post treatment
Tumor Response will be evaluated using the RECIST 1.1 criteria.ORR is Partial response (PR) and complete response (CR).
3 secondary outcomes
Treatment toxicities
Time frame: up to 12 months
Progression-free survival(PFS)
Time frame: up to 12 months
Overall survival(OS)
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Bing Lu, MD contact
ShengFa Su, PhD,MD principal investigator
The Affiliated Hospital Of Guizhou Medical University
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 irinotecan plus lobaplatin and irinotecan in people with Small-cell Lung Cancer, run by ShengFa Su 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 9 inclusion and 4 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 5 Feb 2020. 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 ShengFa Su, PhD,MD (0086-851-86513076, sushengfa2005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: >4 weeks post treatment). 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 5 Feb 2020.