Small Cell Lung Cancer (SCLC)Phase 2NCT02769832
Nab-Paclitaxel With Gemcitabine for Relapsed Small Cell Cancer
A Phase 2 study testing Nab-paclitaxel and Gemcitabine in people with Small Cell Lung Cancer (SCLC), run by Muhammad Furqan at 1 site in United States.
Trial summary
The purpose of this research study is to see if Abraxane and Gemcitabine given together will be effective in treating small cell cancer that has progressed after one line of treatment. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Small Cell Lung Cancer (SCLC)
- What is being tested?
- Nab-paclitaxel and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2016to 7 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, both male and female
- Histologically or cytologically confirmed SCLC SCLC or small cell cancer from other organs or poorly differentiated neuroendocrine tumors that are treated like small cell cancer. This study is for patients with metastatic or recurrent disease.
- ECOG performance status 0-2
- Patients must have at least one measurable lesion as defined per RECIST 1.1
- Progression during or after prior first line chemotherapy. Prior maintenance therapy, targeted therapy and immunotherapy are allowed. Prior use of Rovalpituzumab or other ADC agent is allowed. Immunotherapy or targeted therapy if used as 2nd line therapy will not be considered as second line therapy as these are not true chemotherapeutic agents. Patients treated with definitive chemo-radiation will be eligible if they progressed within a year of definitive therapy (as definitive therapy will be considered 1st line therapy for these patients).
- Before study therapy, a minimum of 21 days must have elapsed since any prior chemotherapy and 2 weeks from the last dose of prior targeted or immunotherapy.
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- Prior definitive XRT is allowed if it has been 2 weeks since the end of definitive XRT. For palliative XRT, protocol-specified treatment can begin at minimum 48 hours after completion of radiation. Lesions within the XRT field can only be used as target lesions if definite progression has been demonstrated since the completion of radiation.
- Adequate major organ function including the following:
- Hematologic function: Absolute neutrophil count (ANC) ≥ 1800 /mm3, platelet count ≥ 100,000/mm3, and Hgb ≥ 9.0 gm/dl.
- Hepatic function: bilirubin ≤ 1.5 x ULN, AST and ALT levels ≤ 2.5 x ULN. If liver metastases are present, then AST and ALT ≤ 5 x ULN.
- Renal function: serum creatinine ≤ 1.5 x ULN.
- Patients must be willing and able to sign informed consent for themselves
- If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 6 months after trial. If male, use of an approved contraceptive method during the study and 6 months afterwards. Females with childbearing potential must have a urine negative hCG test within 7 days prior to the study therapy.
- Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:
- Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP therapy (including dose interruptions), and while on study medication or for a longer period if required by local regulations following the last dose of IP; and
- Have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, as per clinical judgement of the investigator, and after the end of study therapy. This applies even if the subject practices true abstinence from heterosexual contact.
- Male subjects must practice true abstinence* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy.
- True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
Who cannot join
- Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects:
- Pregnant women
- Nursing women
- Men or women of childbearing potential, who are unwilling to employ adequate contraception as determined by treating physician, while on this study and for 6 months after the end of treatment with the study drugs.
- History of the following within the prior 6 months: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder
- Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complication of study therapy
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- History of other invasive malignancy that is currently active and/or has been treated within 12 months prior to enrollment (notable exceptions include: basal cell carcinoma, squamous cell carcinoma of the skin, localized prostate cancer, in situe carcinomas of the cervix and breast, and superficial bladder cancers [non-muscle invasive]).
- Psychiatric disorder which, per treating physician discretion, may preclude compliance
- Major surgery in the last two weeks of starting study therapy. This does not include procedures like biopsy (needle or excisional) or port placement as these are not considered as major surgery.
- Individuals with the presence of symptomatic CNS metastasis requiring radiation, surgery, or ongoing use of corticosteroids. Untreated or brain metastasis causing any symptoms. Treated brain metastasis must be stable for 4 weeks prior to first dose of study drug and not require steroids for at least 7 days prior to study treatment.
- Pre-existing peripheral neuropathy > Grade 1 (using CTCAE v 4.3 criteria)
- Received any prior treatment with any taxane (docetaxel or paclitaxel) for small cell lung cancer.
- History of allergy or hypersensitivity to albumin-bound paclitaxel, or gemcitabine.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52317
About this study
Official title: Phase II Study of Nab-Paclitaxel With Gemcitabine for Relapsed Small Cell Cancer or Those With Progression on First Line Therapy
The purpose of this research study is to see if Abraxane and Gemcitabine given together will be effective in treating small cell cancer that has progressed after one line of treatment.
Read the detailed description
This study is designed as a second-line therapy for patients with histologically or cytologically confirmed small cell lung cancer or small cell cancer from other organs or poorly differentiated neuroendocrine tumors that are treated like small cell cancer. This study is for patients with metastatic or recurrent disease. Eligible patients will receive Nab-Paclitaxel (Abraxane), 100 mg/m2, IV over 30 minutes on Days 1 and 8 of a 21-day cycle followed by Gemcitabine, 1000 mg/m2, IV over 30 minutes on Days 1 and 8 of a 21-day cycle. Participants can continue receiving Nab-Paclitaxel and Gemcitabine until disease progression, unacceptable toxicity or withdrawal from the study. Tumor measurements will be done every 2 cycles.
- Conditions
- Small Cell Lung Cancer (SCLC)
- Being tested
- Nab-paclitaxel, Gemcitabine
- Keywords
- Abraxane, Albumin-bound Paclitaxel, SCLC, Gemzar
- 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.
Nab-paclitaxelDrug
Also called albumin-bound paclitaxel; paclitaxel protein-bound particles for injectable suspension (albumin-bound); Nab-paclitaxel Brand name: Abraxane ®
Nab-paclitaxel 100 mg/m2, day 1 and day 8 of a 21-day cycle
GemcitabineDrug
Also called Generic name: gemcitabine; Brand name: Gemzar ®
Gemcitabine 1000 mg/m2, day 1 and day 8 of a 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Nab-Paclitaxel with Gemcitabine | Experimental | Nab-paclitaxel 100 mg/m2, day 1 and day 8 of a 21-day cycle Gemcitabine 1000 mg/m2, day 1 and day 8 of a 21-day cycle Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Overall response rate is defined as the percentage of patients with a confirmed complete or partial response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI/CT scan:
Complete response (CR) is the disappearance of all target lesions. Partial Response (PR), is at least a ≥ 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum of the longest diameter (LD). Progression of disease (PD) is at least a ≥ 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and as defined by RECIST v1.1 guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
Measured: Patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)
Secondary outcomes (3)
Progression-Free Survival
Progression-free survival is defined as the time from treatment initiation to the date of first documentation of disease progression or death due to any cause. Otherwise, patients are censored at the date of last radiographic assessment for progression.
Measured: Patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)
Time to Progression
Time to progression is defined as the time from treatment initiation to the date of first documentation of disease progression per RECIST v1.1. Otherwise, patients are censored at last radiographic assessment for progression.
Measured: Patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)
Overall Survival
Overall survival is defined as the time from treatment initiation to death due to any cause. Patients still alive are censored at last date known to be alive.
Measured: Patients will be evaluated every 3 months until death or study completion (up 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 posted12 May 2016 (estimated)
- Study start29 Aug 2016
- Primary completion23 Sep 2021
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung Cancer (SCLC)Studies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Furqan
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor-investigator, Muhammad Furqan, University of Iowa
- Investigators
- Muhhamad Furqan, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769832
- Sponsor's protocol ID
- 201512799
- Status last verified
- Jul 2025
- First submitted
- 20 Jan 2016
- Last updated
- 29 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Byrne MM, Sutamtewagul G, Zeitler W, Mott SL, Zamba GKD, Kojadinovic A, Zhang J, Abu-Hejleh T, Clamon G, Furqan M. Phase II study of nab-paclitaxel with gemcitabine for relapsed/refractory small cell lung cancer. Front Oncol. 2024 Jul 31;14:1303268. doi: 10.3389/fonc.2024.1303268. eCollection 2024.
PubMed 39144826
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Nab-Paclitaxel With Gemcitabine for Relapsed Small Cell Cancer or Those With Progression on First Line Therapy
- ClinicalTrials.gov ID
- NCT02769832
- Acronym / sponsor ID
- 201512799
- Conditions
- Small Cell Lung Cancer (SCLC)
- Keywords
- Abraxane, Albumin-bound Paclitaxel, SCLC, Gemzar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Muhammad FurqanUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- 29 Aug 2016 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Posted 21 Jul 2023
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 research study is to see if Abraxane and Gemcitabine given together will be effective in treating small cell cancer that has progressed after one line of treatment.
Detailed description
This study is designed as a second-line therapy for patients with histologically or cytologically confirmed small cell lung cancer or small cell cancer from other organs or poorly differentiated neuroendocrine tumors that are treated like small cell cancer. This study is for patients with metastatic or recurrent disease. Eligible patients will receive Nab-Paclitaxel (Abraxane), 100 mg/m2, IV over 30 minutes on Days 1 and 8 of a 21-day cycle followed by Gemcitabine, 1000 mg/m2, IV over 30 minutes on Days 1 and 8 of a 21-day cycle. Participants can continue receiving Nab-Paclitaxel and Gemcitabine until disease progression, unacceptable toxicity or withdrawal from the study. Tumor measurements will be done every 2 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nab-Paclitaxel with Gemcitabine | Experimental | Drug: Nab-paclitaxel, Drug: GemcitabineNab-paclitaxel 100 mg/m2, day 1 and day 8 of a 21-day cycle Gemcitabine 1000 mg/m2, day 1 and day 8 of a 21-day cycle |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥18 years old, both male and female
- Histologically or cytologically confirmed SCLC SCLC or small cell cancer from other organs or poorly differentiated neuroendocrine tumors that are treated like small cell cancer. This study is for patients with metastatic or recurrent disease.
- ECOG performance status 0-2
- Patients must have at least one measurable lesion as defined per RECIST 1.1
- Progression during or after prior first line chemotherapy. Prior maintenance therapy, targeted therapy and immunotherapy are allowed. Prior use of Rovalpituzumab or other ADC agent is allowed. Immunotherapy or targeted therapy if used as 2nd line therapy will not be considered as second line therapy as these are not true chemotherapeutic agents. Patients treated with definitive chemo-radiation will be eligible if they progressed within a year of definitive therapy (as definitive therapy will be considered 1st line therapy for these patients).
Key exclusion criteria (13 listed)
- Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects:
- History of the following within the prior 6 months: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder
- Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complication of study therapy
- History of other invasive malignancy that is currently active and/or has been treated within 12 months prior to enrollment (notable exceptions include: basal cell carcinoma, squamous cell carcinoma of the skin, localized prostate cancer, in situe carcinomas of the cervix and breast, and superficial bladder cancers [non-muscle invasive]).
- Psychiatric disorder which, per treating physician discretion, may preclude compliance
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 |
|---|---|---|
| Nab-paclitaxelAlso: albumin-bound paclitaxel; paclitaxel protein-bound particles for injectable suspension (albumin-bound); Nab-paclitaxel Brand name: Abraxane ®Nab-paclitaxel 100 mg/m2, day 1 and day 8 of a 21-day cycle | Drug | Nab-Paclitaxel with Gemcitabine |
| GemcitabineAlso: Generic name: gemcitabine; Brand name: Gemzar ®Gemcitabine 1000 mg/m2, day 1 and day 8 of a 21-day cycle | Drug | Nab-Paclitaxel with Gemcitabine |
Primary outcome
Overall Response Rate
Time frame: Patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)
Overall response rate is defined as the percentage of patients with a confirmed complete or partial response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI/CT scan: Complete response (CR) is the disappearance of all target lesions. Partial Response (PR), is at least a ≥ 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum of the longest diameter (LD). Progression of disease (PD) is at least a ≥ 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and as defined by RECIST v1.1 guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
3 secondary outcomes
Progression-Free Survival
Time frame: Patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)
Time to Progression
Time frame: Patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)
Overall Survival
Time frame: Patients will be evaluated every 3 months until death or study completion (up to 3 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39144826Byrne MM, Sutamtewagul G, Zeitler W, Mott SL, Zamba GKD, Kojadinovic A, Zhang J, Abu-Hejleh T, Clamon G, Furqan M. Phase II study of nab-paclitaxel with gemcitabine for relapsed/refractory small cell lung cancer. Front Oncol. 2024 Jul 31;14:1303268. doi: 10.3389/fonc.2024.1303268. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Muhhamad Furqan, MD principal investigator
University of Iowa
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 Nab-paclitaxel and Gemcitabine in people with Small Cell Lung Cancer (SCLC), run by Muhammad Furqan at 1 site in United States.
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 18 inclusion and 13 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 29 Jul 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 21 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (time frame: Patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02769832, which also lists 1 linked publication.
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 29 Jul 2025.