Extensive-Stage Small Cell Lung CancerPhase 2NCT04056949
Efficacy and Safety of IBI308 and Paclitaxel/Albumin Paclitaxel for SCLC Patients Who Failed Etoposide Chemotherapy
A Phase 2 study testing Paclitaxel/Albumin-Bound Paclitaxel and IBI308 in people with Extensive-Stage Small Cell Lung Cancer, run by Junling Li at 1 site in China.
Trial summary
This phase II trial studies how well IBI308 combined with paclitaxel/albumin-bound paclitaxel work in treating participants with small cell lung cancer after failing to platinum-etoposide chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Extensive-Stage Small Cell Lung Cancer
- What is being tested?
- Paclitaxel/Albumin-Bound Paclitaxel and IBI308
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent;
- Over 18 years old and below 70 years old;
- Histologically confirmed small-cell lung cancer;
- Extensive disease(ED) according to the criteria of the Veteran's Administration Lung Cancer Group: (disease extended is defined as a disease beyond hemi thorax and supraclavicular lymph node areas.);
- ED-SCLC treated with platinum-etoposide chemotherapy ,followed by disease progression or recurrence.
- Availability of a biomarker detection tissue biopsy is required;
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- Eastern Cooperative Oncology Group (ECOG) performance status 0~1;
- Life expectancy of greater than 12 weeks;
- Participants may have evaluable or measurable disease, defined as at least one lesion（no previous radiotherapy）that can be accurately measured in at least one dimension with spiral CT scan, MRI within the past 28 days;
- Women of child-bearing potential and men must agree to use adequate contraception prior to initiation of therapy and until to 6 month after this study;
- White blood cell ≥ 3.5 × 109/L, absolute neutrophil count ≥1.5 × 109/L, platelet ≥100× 109/L and hemoglobin ≥9.0 g/dL;
- Aspartate transferase,alanine aminotransferase ≤ 2.5 x ULN except in case of liver metastases (5 x ULN); Total bilirubin ≤1.5 x ULN except in case of Gilbert syndrome (3.0 mg/dL); Albumin≥3 g/dL;
- Serum creatinine ≤1.5×ULN OR creatinine clearance≥40 mL/min;
- Lipase < 1.5 x ULN except in case of having no clinical or imaging evidence of pancreatitis; Amylase ≤1.5 x ULN except in case of having no clinical or imaging evidence of pancreatitis; Alkaline phosphatase (ALP) ≤ 2.5 ULN except in case of bone metastasis;
Who cannot join
- Mixed lung cancer or other types of lung cancer;
- Prior immunotherapy, included but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other drugs targeting T cells;
- Received high-dose radiation therapy in thoracic field within the past 6 months, Dt (> 30 Gy);
- Active or untreated central nervous system (CNS) metastases;
- Patients with cytologically positive pleural, peritoneal or pericardial fluid are not eligible;
- History of autoimmune disease.Patients with a history of hypothyroidism origin autoimmune treated with a stable dose replacement therapy may be eligible for this study. Patients with controlled type 1 diabetes treated with insulin are eligible in this study;
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- Corticosteroid with a daily dose over 10 mg prednisolone or other immunosuppressive agents were used within 14 days before the first cycle;
- Patients should not receive a vaccine during the four weeks preceding the day 1 of cycle 1, and shall not receive a vaccine during the study;
- Idiopathic pulmonary fibrosis history, radioactive pneumonia requiring steroid therapy, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced lung disease, idiopathic pulmonary or active signs of pneumonia or interstitial lung infiltrate (any cause) detected on the lung scan selection;
- History of active Bacillus Tuberculosis;
- Except hair loss and fatigue, toxicities caused by previous anti-cancer therapies need to be restored to < CTCAE 4.03 grade 1 before starting treatment on protocol;
- History of any one or more of the following conditions within the past 6 months:symptomatic peripheral vascular disease, pulmonary embolism or untreated deep venous thrombosis (DVT), cerebrovascular accident or transient ischemic attack;
- History of any one or more of the following conditions within the past 6 months: gastrointestinal ulcer, gastrointestinal perforation, corrosive esophagitis or gastritis, inflammatory bowel disease or diverticulitis, abdominal fistula, tracheoesophageal fistula or abdominal abscess;
- History of any one or more of the following cardiovascular conditions: Class III or IV congestive heart failure, as defined by the New York Heart Association; Unstable angina; Myocardial infarction within the past 6 months; Supraventricular or ventricular arrhythmia requires treatment or intervention;
- Severe uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100mmHg);
- Tumors compress surrounding vital organs, such as the esophagus, with associated symptoms;
- Uncontrolled hypercalcemia;
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to monoclonal antibody;
- Prior malignancy. Note: Patients who have had another malignancy and were treated more than 5 years ago and have since been considered cured, or patients with a history of basocellular skin carcinoma or in situ carcinoma of the uterine cervix are eligible;
- Mental illness, alcoholism, inability to quit smoking, drug abuse or drug abuse;
- History of human immunodeficiency virus infection or has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C Virus (HCV) (e.g., HCV RNA is detected).
- Pregnant or lactating female;
- Any type of systemic anticancer therapy (chemotherapy or experimental drugs) within 4 weeks of starting treatment on protocol;
- Other situations judged by researchers;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Junling Li
Beijing, Beijing Municipality, 100021
Junling Li, Doctor, +86 13801178891, lijunling@cicams.ac.cn
About this study
Official title: The Efficacy and Safety of IBI308 Combined With Paclitaxel/Albumin-Bound Paclitaxel as Second-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer That Relapsed After Failing to Platinum-Etoposide Chemotherapy
This phase II trial studies how well IBI308 combined with paclitaxel/albumin-bound paclitaxel work in treating participants with small cell lung cancer after failing to platinum-etoposide chemotherapy.
Read the detailed description
Primary objective :
To estimate progression free survival (PFS) probability of patient who recurrent SCLC treated with IBI308 combined with paclitaxel/abumin-bound paclitaxel following progression on platinum-etoposide chemotherapy.
Secondary Objectives:
I.To evaluate the objective remission rate (ORR), disease control rate. (DCR),durative time of remission ( DoR）and overall survival (OS) of IBI308 combined with paclitaxel/abumin-bound paclitaxel following progression on platinum-etoposide chemotherapy.
II.To evaluate the safety of IBI308 combined with paclitaxel/abumin-bound paclitaxel following progression on platinum-etoposide chemotherapy.
Exploratory Objectives To evaluate the correlation of biomarkers with efficacy and toxicity.
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Being tested
- Paclitaxel/Albumin-Bound Paclitaxel, IBI308
- Keywords
- SCLC
- 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.
Paclitaxel/Albumin-Bound PaclitaxelDrug
Paclitaxel 175mg/m2 IV on day 1of 21 days cycle ;Number of Cycles: 4-6; or Albumin-bound paclitaxel 130mg/m2 IV on day 1 and 8 of 21 days cycle ;Number of Cycles: 4-6;
IBI308Drug
IBI308 200mg IV infusion, every 3 weeks,until disease progress or intolerable toxicity,used up to 1 year (or 16 cycles)
| Study group | Role | What they receive |
|---|---|---|
| IBI308 + Paclitaxel/Albumin-Bound Paclitaxel | Other | IBI308 Combined with Albumin-Bound Paclitaxe Receives: Drug: Paclitaxel/Albumin-Bound Paclitaxel; Drug: IBI308 |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
Measured: 12 months
Secondary outcomes (4)
overall survival (OS)
Measured: 12 months
disease control rate (DCR)
Measured: 12 months
durative time of remission ( DoR）
Measured: 12 months
objective remission rate (ORR)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start5 Aug 2019
- Primary completion1 Feb 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-Stage 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
- SCLC patients who have failed platinum-etoposide chemotherapy
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Junling Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Junling Li, Peking Union Medical College
- Investigators
- Junling Li, doctor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056949
- Sponsor's protocol ID
- NCC1977
- Status last verified
- Aug 2019
- First submitted
- 9 Aug 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of IBI308 Combined With Paclitaxel/Albumin-Bound Paclitaxel as Second-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer That Relapsed After Failing to Platinum-Etoposide Chemotherapy
- ClinicalTrials.gov ID
- NCT04056949
- Acronym / sponsor ID
- NCC1977
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Keywords
- SCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Junling LiUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 14 Aug 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.
This phase II trial studies how well IBI308 combined with paclitaxel/albumin-bound paclitaxel work in treating participants with small cell lung cancer after failing to platinum-etoposide chemotherapy.
Detailed description
Primary objective :
To estimate progression free survival (PFS) probability of patient who recurrent SCLC treated with IBI308 combined with paclitaxel/abumin-bound paclitaxel following progression on platinum-etoposide chemotherapy.
Secondary Objectives:
I.To evaluate the objective remission rate (ORR), disease control rate. (DCR),durative time of remission ( DoR）and overall survival (OS) of IBI308 combined with paclitaxel/abumin-bound paclitaxel following progression on platinum-etoposide chemotherapy.
II.To evaluate the safety of IBI308 combined with paclitaxel/abumin-bound paclitaxel following progression on platinum-etoposide chemotherapy.
Exploratory Objectives To evaluate the correlation of biomarkers with efficacy and toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SCLC patients who have failed platinum-etoposide chemotherapy
| Arm | Type | Receives |
|---|---|---|
| IBI308 + Paclitaxel/Albumin-Bound Paclitaxel | Other | Drug: Paclitaxel/Albumin-Bound Paclitaxel, Drug: IBI308IBI308 Combined with Albumin-Bound Paclitaxe |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed informed consent;
- Over 18 years old and below 70 years old;
- Histologically confirmed small-cell lung cancer;
- Extensive disease(ED) according to the criteria of the Veteran's Administration Lung Cancer Group: (disease extended is defined as a disease beyond hemi thorax and supraclavicular lymph node areas.);
- ED-SCLC treated with platinum-etoposide chemotherapy ,followed by disease progression or recurrence.
Key exclusion criteria (24 listed)
- Mixed lung cancer or other types of lung cancer;
- Prior immunotherapy, included but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other drugs targeting T cells;
- Received high-dose radiation therapy in thoracic field within the past 6 months, Dt (> 30 Gy);
- Active or untreated central nervous system (CNS) metastases;
- Patients with cytologically positive pleural, peritoneal or pericardial fluid are not eligible;
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 |
|---|---|---|
| Paclitaxel/Albumin-Bound PaclitaxelPaclitaxel 175mg/m2 IV on day 1of 21 days cycle ;Number of Cycles: 4-6; or Albumin-bound paclitaxel 130mg/m2 IV on day 1 and 8 of 21 days cycle ;Number of Cycles: 4-6; | Drug | IBI308 + Paclitaxel/Albumin-Bound Paclitaxel |
| IBI308IBI308 200mg IV infusion, every 3 weeks,until disease progress or intolerable toxicity,used up to 1 year (or 16 cycles) | Drug | IBI308 + Paclitaxel/Albumin-Bound Paclitaxel |
Primary outcome
progression-free survival (PFS)
Time frame: 12 months
4 secondary outcomes
overall survival (OS)
Time frame: 12 months
disease control rate (DCR)
Time frame: 12 months
durative time of remission ( DoR）
Time frame: 12 months
objective remission rate (ORR)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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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.
Junling Li, doctor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Paclitaxel/Albumin-Bound Paclitaxel and IBI308 in people with Extensive-Stage Small Cell Lung Cancer, run by Junling Li 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 14 inclusion and 24 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 14 Aug 2019. 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 Junling Li, doctor (+86 13801178891, lijunling@cicams.ac.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: 12 months). 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 Aug 2019.