Carcinoma, Non-Small-Cell LungPhase 2C-TONG1002NCT01236716
Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung
A Phase 2 study testing Albumin paclitaxel plus carboplatin and Gemcitabine plus carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Chinese Society of Lung Cancer at 1 site in China.
Trial summary
This trial is to study the efficacy of nab-PC vs. GC and evaluate toxicity of nab-PC in advanced squamous cell cancer of lung. The correlation between the efficacy of nab-PC and some biomarkers is also to be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Albumin paclitaxel plus carboplatin and Gemcitabine plus carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- Nov 2010to Jun 2014
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated, histological documented stage IIIB (not amenable for radical regional therapy) or stage IV squamous cell carcinoma of lung. At least one measurable lesion as defined by RECIST criteria.
- At least 18 years of age.
- ECOG PS 0~1
- Patients have no previously malignant tumor history except cured cervical carcinoma in situ, basal cell carcinoma or superficial bladder cancer. Patients are also eligible if they have received a chemotherapy regimen as neoadjuvant or adjuvant chemotherapy and the disease recurred over 12 months since the finishing of neoadjuvant or adjuvant chemotherapy.
- neutrophil ≥ 1.5 x 109 /L, Hemoglobin > 90 g/L, Platelet count > 100x109/L.
- Total bilirubin ≤ 1.5 x upper limit of normal. ALT and AST < 2.5 x upper limit of normal without liver metastasis, ALT and AST < 5 x upper limit of normal with liver metastasis. Serum creatinine < 1.5 x upper limit of normal.
Show all 10Show fewer
- Urine pregnancy test is negative for woman.
- Estimated life expectancy is at least 3 months.
- Patient comply with the clinical trial protocal.
- Informed consent must be signed.
Who cannot join
- Patients who are currently undergoing other anti-tumor therapy.
- Patients who was enrolled in any other clinical trial within 4 weeks of study entry.
- Any physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any study medication or render the subject at high risk from treatment.
- Central nervous system (CNS) tumor or metastatic tumor.
- Serious mental disorder.
- Serious dysgnosia.
Show all 9Show fewer
- Other serious comorbidity.
- Alcohol or drug dependence.
- Previously allergic to drugs used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase II Clinical Trial of Nab-Paclitaxel and Carboplatin Compared With Gemcitabine and Carboplatin as First-line Therapy in Advanced Squamous Cell Carcinoma of Lung
This trial is to study the efficacy of nab-PC vs. GC and evaluate toxicity of nab-PC in advanced squamous cell cancer of lung. The correlation between the efficacy of nab-PC and some biomarkers is also to be evaluated.
Read the detailed description
Albumin-bound paclitaxel(nab-P) utilizes the albumin binding proteins,such as (gp60)/caveolin-1 (CAV1) and SPARC(secreted protein acidic and rich in cysteine), achieving high intratumoral paclitaxel accumulation. It is reported that CAV1 is overexpressed in squamous cell cancer(SQC), so it is possible that nab-PC is more highly active than GC in SQC of lung.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Albumin paclitaxel plus carboplatin, Gemcitabine plus carboplatin
- Keywords
- squamous cell carcinoma of lung, Albumin bound paclitaxel, chemotherapy
- 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.
Albumin paclitaxel plus carboplatinDrug
Also called Abraxane(Albumin-bound paclitaxel,nab-P)
Patients receive carboplatin AUC=5 q3w and nab-p 135 mg/m2 weekly for 2 weeks (on days 1 and 8 of a 21-day cycle), followed by a week of rest.
Gemcitabine plus carboplatinDrug
Also called Gemzar(Gemcitabine)
Patients receive carboplatin AUC=5 q3w and gemcitabine 1250 mg/m2 weekly for 2 weeks (on days 1 and 8 of a 21-day cycle), followed by a week of rest.
| Study group | Role | What they receive |
|---|---|---|
| Albumin paclitaxel plus carboplatin | Experimental | Treatment of Albumin paclitaxel plus carboplatin Receives: Drug: Albumin paclitaxel plus carboplatin |
| Gemcitabine plus carboplatin | Active comparator | Treatment of Gemcitabine plus carboplatin Receives: Drug: Gemcitabine plus carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate(ORR)
ORR is evaluated after at most 6 cycles of chemotherapy, which may cost 18 weeks.
Measured: 18weeks
Secondary outcomes (1)
Response duration, progression free survival, overall survival, safety profile
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Society of Lung Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Long Wu, Chinese Society of Lung Cancer
- Investigators
- Wu Yilong, professor, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236716
- Sponsor's protocol ID
- C-TONG1002
- Acronym
- C-TONG1002
- Status last verified
- Aug 2014
- First submitted
- 8 Nov 2010
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang Z, Huang C, Yang JJ, Song Y, Cheng Y, Chen GY, Yan HH, Ben XS, Wang BC, Xu CR, Jiang BY, Zhou Q, Chen HJ, Wu YL. A randomised phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in advanced squamous cell lung carcinoma (C-TONG1002). Eur J Cancer. 2019 Mar;109:183-191. doi: 10.1016/j.ejca.2019.01.007. Epub 2019 Feb 7.
PubMed 30739019Yang JJ, Huang C, Chen GY, Song Y, Cheng Y, Yan HH, Zhou Q, Wu YL. A randomized phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in locally advanced or metastatic squamous cell carcinoma of lung. BMC Cancer. 2014 Sep 20;14:684. doi: 10.1186/1471-2407-14-684.
PubMed 25239521Gold KA, Wistuba II, Kim ES. New strategies in squamous cell carcinoma of the lung: identification of tumor drivers to personalize therapy. Clin Cancer Res. 2012 Jun 1;18(11):3002-7. doi: 10.1158/1078-0432.CCR-11-2055. Epub 2012 Mar 29.
PubMed 22461458
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Clinical Trial of Nab-Paclitaxel and Carboplatin Compared With Gemcitabine and Carboplatin as First-line Therapy in Advanced Squamous Cell Carcinoma of Lung
- ClinicalTrials.gov ID
- NCT01236716
- Acronym / sponsor ID
- C-TONG1002 / C-TONG1002
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- squamous cell carcinoma of lung, Albumin bound paclitaxel, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Chinese Society of Lung CancerUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Nov 2010 (estimated)
- 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 trial is to study the efficacy of nab-PC vs. GC and evaluate toxicity of nab-PC in advanced squamous cell cancer of lung. The correlation between the efficacy of nab-PC and some biomarkers is also to be evaluated.
Detailed description
Albumin-bound paclitaxel(nab-P) utilizes the albumin binding proteins,such as (gp60)/caveolin-1 (CAV1) and SPARC(secreted protein acidic and rich in cysteine), achieving high intratumoral paclitaxel accumulation. It is reported that CAV1 is overexpressed in squamous cell cancer(SQC), so it is possible that nab-PC is more highly active than GC in SQC of lung.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin paclitaxel plus carboplatin | Experimental | Drug: Albumin paclitaxel plus carboplatinTreatment of Albumin paclitaxel plus carboplatin |
| Gemcitabine plus carboplatin | Active comparator | Drug: Gemcitabine plus carboplatinTreatment of Gemcitabine plus carboplatin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Previously untreated, histological documented stage IIIB (not amenable for radical regional therapy) or stage IV squamous cell carcinoma of lung. At least one measurable lesion as defined by RECIST criteria.
- At least 18 years of age.
- ECOG PS 0~1
- Patients have no previously malignant tumor history except cured cervical carcinoma in situ, basal cell carcinoma or superficial bladder cancer. Patients are also eligible if they have received a chemotherapy regimen as neoadjuvant or adjuvant chemotherapy and the disease recurred over 12 months since the finishing of neoadjuvant or adjuvant chemotherapy.
- neutrophil ≥ 1.5 x 109 /L, Hemoglobin > 90 g/L, Platelet count > 100x109/L.
Key exclusion criteria (9 listed)
- Patients who are currently undergoing other anti-tumor therapy.
- Patients who was enrolled in any other clinical trial within 4 weeks of study entry.
- Any physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any study medication or render the subject at high risk from treatment.
- Central nervous system (CNS) tumor or metastatic tumor.
- Serious mental disorder.
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 |
|---|---|---|
| Albumin paclitaxel plus carboplatinAlso: Abraxane(Albumin-bound paclitaxel,nab-P)Patients receive carboplatin AUC=5 q3w and nab-p 135 mg/m2 weekly for 2 weeks (on days 1 and 8 of a 21-day cycle), followed by a week of rest. | Drug | Albumin paclitaxel plus carboplatin |
| Gemcitabine plus carboplatinAlso: Gemzar(Gemcitabine)Patients receive carboplatin AUC=5 q3w and gemcitabine 1250 mg/m2 weekly for 2 weeks (on days 1 and 8 of a 21-day cycle), followed by a week of rest. | Drug | Gemcitabine plus carboplatin |
Primary outcome
Overall response rate(ORR)
Time frame: 18weeks
ORR is evaluated after at most 6 cycles of chemotherapy, which may cost 18 weeks.
1 secondary outcome
Response duration, progression free survival, overall survival, safety profile
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
- Derived from this study: PubMed 30739019Wang Z, Huang C, Yang JJ, Song Y, Cheng Y, Chen GY, Yan HH, Ben XS, Wang BC, Xu CR, Jiang BY, Zhou Q, Chen HJ, Wu YL. A randomised phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in advanced squamous cell lung carcinoma (C-TONG1002). Eur J Cancer. 2019 Mar;109:183-191. doi: 10.1016/j.ejca.2019.01.007. Epub 2019 Feb 7.
- Derived from this study: PubMed 25239521Yang JJ, Huang C, Chen GY, Song Y, Cheng Y, Yan HH, Zhou Q, Wu YL. A randomized phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in locally advanced or metastatic squamous cell carcinoma of lung. BMC Cancer. 2014 Sep 20;14:684. doi: 10.1186/1471-2407-14-684.
- Derived from this study: PubMed 22461458Gold KA, Wistuba II, Kim ES. New strategies in squamous cell carcinoma of the lung: identification of tumor drivers to personalize therapy. Clin Cancer Res. 2012 Jun 1;18(11):3002-7. doi: 10.1158/1078-0432.CCR-11-2055. Epub 2012 Mar 29.
Related trials for Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Wu Yilong, professor principal investigator
Guangdong Provincial People's 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 Albumin paclitaxel plus carboplatin and Gemcitabine plus carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Chinese Society of Lung Cancer 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 10 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: finished, as of the sponsor's last update on 6 Aug 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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(ORR) (time frame: 18weeks). 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 NCT01236716, which also lists 3 linked publications.
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 6 Aug 2014.