Advanced Squamous Non-Small Cell Lung CancerPhase 1/2NCT00807612
QUILT-2.017: Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for 1st Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer
A Phase 1/2 study testing AMG 479, Carboplatin and Paclitaxel in people with Advanced Squamous Non-Small Cell Lung Cancer, run by NantCell, Inc. at 25 sites in United States.
Trial summary
This is a global, multicenter, 2-part, open-label phase 1b and single-arm phase 2 study designed to evaluate the safety and efficacy of AMG 479 in combination with paclitaxel and carboplatin for the first-line treatment of advanced squamous non-small cell lung carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Squamous Non-Small Cell Lung Cancer
- What is being tested?
- AMG 479, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 25 sitesUnited States
- Study dates
- Jan 2009to Aug 2010
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed advanced squamous NSCLC
- Measurable disease as defined per modified RECIST criteria
- ECOG performance status of 0 or 1
- ≥18 years old
- Adequate glycemic function, for subjects with known diabetes
Who cannot join
- Untreated or symptomatic central nervous system (CNS) metastases
- Prior anti-cancer therapy as follows: Any prior chemotherapy for squamous NSCLC; Any prior adjuvant or neoadjuvant chemotherapy for squamous NSCLC; Any prior chemoradiation for squamous NSCLC; Central (chest) radiation therapy ≤ 28 days prior to enrollment, radiation therapy for peripheral lesions≤14 days prior to enrollment for squamous NSCLC
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Research Site
Bethlehem, Pennsylvania, 18015
Research Site
Bethlehem, Pennsylvania
Research Site
Fayetteville, Arkansas, 72703
Research Site
Fayetteville, Arkansas
Research Site
Fort Wayne, Indiana, 46845
Research Site
Fort Wayne, Indiana
Research Site
Greenville, South Carolina, 29605
Research Site
Greenville, South Carolina
Research Site
Indianapolis, Indiana, 46202
Research Site
Indianapolis, Indiana, 46256
Research Site
Indianapolis, Indiana
Research Site
Lafayette, Indiana, 47905
Research Site
Lafayette, Indiana
Research Site
Madison, Wisconsin, 53792
Research Site
Madison, Wisconsin
Research Site
Memphis, Tennessee, 38120
Research Site
Memphis, Tennessee
Research Site
New Albany, Indiana, 47150
Research Site
New Albany, Indiana
Research Site
Paducah, Kentucky, 42003
Research Site
Paducah, Kentucky
Research Site
St Louis, Missouri, 63110-1093
Research Site
St Louis, Missouri
Research Site
Winston-Salem, North Carolina, 27103
Research Site
Winston-Salem, North Carolina
About this study
Official title: A Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer
This is a global, multicenter, 2-part, open-label phase 1b and single-arm phase 2 study designed to evaluate the safety and efficacy of AMG 479 in combination with paclitaxel and carboplatin for the first-line treatment of advanced squamous non-small cell lung carcinoma.
- Being tested
- AMG 479, Carboplatin, Paclitaxel
- Keywords
- AMG 479, IGF-1R, Apoptosis, Monoclonal Antibody, Advanced Squamous Non-Small Cell Lung Cancer, antibody 1st-line
- Medical subject headings
- Insulin-Like Growth Factor I, Resistance To
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 479Biological
AMG 479 at 12 mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 12 mg/kg IV monotherapy for up to 24 months from study day 1
AMG 479Biological
AMG 479 at 18mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on Day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 18 mg/kg IV monotherapy for up to 24 months from day 1
CarboplatinDrug
Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6
AMG 479Biological
AMG 479 IV in combination with chemotherapy on day 1 of every 3 week cycle for 4 to 6 cycles, followed by AMG 479 IV monotherapy for up to 24 months from study day 1. The AMG 479 dose to be used will be the final AMG 479 dose explored from Part 1
PaclitaxelDrug
Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Cohort 1 | Experimental | AMG 479 at 18 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 18 mg/kg monotherapy for 24 months from study day 1 Receives: Biological: AMG 479; Drug: Carboplatin; Drug: Paclitaxel |
| Part 1 Cohort 2 | Experimental | AMG 479 at 12 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 12 mg/kg monotherapy for 24 months from study day 1 Receives: Biological: AMG 479; Drug: Carboplatin; Drug: Paclitaxel |
| Part 2 | Experimental | AMG 479 in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 monotherapy for 24 months from study day 1
(AMG 479 dose in Part 2 will be the final AMG 479 dose from Part 1) Receives: Drug: Carboplatin; Biological: AMG 479; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Dose Limiting Toxicities
DLTs were defined as grade 3 or higher hematological or nonhematological toxicities that, in the opinion of the investigator, were related to ganitumab or the combination of ganitumab and paclitaxel or carboplatin during this period. These did not include fatigue, nausea, diarrhea, vomiting, hyperglycemia, neutropenia, thrombocytopenia, anemia, lymphopenia, alopecia, increased ALT or AST, or pulmonary embolism unless they met certain criteria.
Measured: Part 1 only up to 21 days
Part 2: Objective Response Rate
Part 2: Objective Response Rate as per modified RECIST criteria by investigator review Objective response was defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors [RECIST] and was determined only for subjects with measurable disease at baseline. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From start of treatment up to approximately 16 months
Secondary outcomes (4)
Number of Participants With Adverse Events
Adverse events were assessed using CTCAE v 3.0
Measured: 30 days after last dose, up to 5 months
Number of Participants With Anti-AMG 479 Antibody Formation
Measured: From start of treatment up to approximately 16 months
Progression Free Survival
PFS was defined as the time from study day 1 to the first observation of disease progression per investigator review (as classified by modified RECIST or death due to any cause, or censoring. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Measured: From start of treatment up to approximately 16 months
Time to Progression and Duration of Response
Time to Progression (TTP) is defined as the time from Day 1 to the first observation of disease progression (per modified RECIST). Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression. DOR was the time from the first observation of an objective response to the subsequent time of disease progression (per modified RECIST or clinical progression, whichever came first) or death due to any cause. Objective response = a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors [RECIST]. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From start of treatment up to approximately 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: Study was closed due to administrative decision
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.
- Other trials for Advanced Squamous Non-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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NantCell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807612
- Sponsor's protocol ID
- 20080257
- Other IDs
- QUILT-2.017
- Status last verified
- Sep 2024
- First submitted
- 11 Dec 2008
- Last updated
- 25 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00807612
- Acronym / sponsor ID
- 20080257
- Keywords
- AMG 479, IGF-1R, Apoptosis, Monoclonal Antibody, Advanced Squamous Non-Small Cell Lung Cancer, antibody 1st-line
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was closed due to administrative decision
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NantCell, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 12 Dec 2008 (estimated)
- Results
- Posted 25 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a global, multicenter, 2-part, open-label phase 1b and single-arm phase 2 study designed to evaluate the safety and efficacy of AMG 479 in combination with paclitaxel and carboplatin for the first-line treatment of advanced squamous non-small cell lung carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1 | Experimental | Biological: AMG 479, Drug: Carboplatin, Drug: PaclitaxelAMG 479 at 18 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 18 mg/kg monotherapy for 24 months from study day 1 |
| Part 1 Cohort 2 | Experimental | Biological: AMG 479, Drug: Carboplatin, Drug: PaclitaxelAMG 479 at 12 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 12 mg/kg monotherapy for 24 months from study day 1 |
| Part 2 | Experimental | Drug: Carboplatin, Biological: AMG 479, Drug: PaclitaxelAMG 479 in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 monotherapy for 24 months from study day 1 (AMG 479 dose in Part 2 will be the final AMG 479 dose from Part 1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed advanced squamous NSCLC
- Measurable disease as defined per modified RECIST criteria
- ECOG performance status of 0 or 1
- ≥18 years old
- Adequate glycemic function, for subjects with known diabetes
Key exclusion criteria (2 listed)
- Untreated or symptomatic central nervous system (CNS) metastases
- Prior anti-cancer therapy as follows: Any prior chemotherapy for squamous NSCLC; Any prior adjuvant or neoadjuvant chemotherapy for squamous NSCLC; Any prior chemoradiation for squamous NSCLC; Central (chest) radiation therapy ≤ 28 days prior to enrollment, radiation therapy for peripheral lesions≤14 days prior to enrollment for squamous NSCLC
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 |
|---|---|---|
| AMG 479AMG 479 at 12 mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 12 mg/kg IV monotherapy for up to 24 months from study day 1 | Biological | Part 1 Cohort 2 |
| AMG 479AMG 479 at 18mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on Day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 18 mg/kg IV monotherapy for up to 24 months from day 1 | Biological | Part 1 Cohort 1 |
| CarboplatinCarboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6 | Drug | Part 1 Cohort 1, Part 1 Cohort 2, Part 2 |
| AMG 479AMG 479 IV in combination with chemotherapy on day 1 of every 3 week cycle for 4 to 6 cycles, followed by AMG 479 IV monotherapy for up to 24 months from study day 1. The AMG 479 dose to be used will be the final AMG 479 dose explored from Part 1 | Biological | Part 2 |
| PaclitaxelPaclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6 | Drug | Part 1 Cohort 1, Part 1 Cohort 2, Part 2 |
Primary outcome
Part 1: Number of Dose Limiting Toxicities
Time frame: Part 1 only up to 21 days
DLTs were defined as grade 3 or higher hematological or nonhematological toxicities that, in the opinion of the investigator, were related to ganitumab or the combination of ganitumab and paclitaxel or carboplatin during this period. These did not include fatigue, nausea, diarrhea, vomiting, hyperglycemia, neutropenia, thrombocytopenia, anemia, lymphopenia, alopecia, increased ALT or AST, or pulmonary embolism unless they met certain criteria.
Part 2: Objective Response Rate
Time frame: From start of treatment up to approximately 16 months
Part 2: Objective Response Rate as per modified RECIST criteria by investigator review Objective response was defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors [RECIST] and was determined only for subjects with measurable disease at baseline. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
4 secondary outcomes
Number of Participants With Adverse Events
Time frame: 30 days after last dose, up to 5 months
Number of Participants With Anti-AMG 479 Antibody Formation
Time frame: From start of treatment up to approximately 16 months
Progression Free Survival
Time frame: From start of treatment up to approximately 16 months
Time to Progression and Duration of Response
Time frame: From start of treatment up to approximately 16 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AMG 479, Carboplatin and Paclitaxel in people with Advanced Squamous Non-Small Cell Lung Cancer, run by NantCell, Inc. at 25 sites 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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 25 Sep 2024). 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?
Part 1: Number of Dose Limiting Toxicities (time frame: Part 1 only up to 21 days). The study lists 2 primary outcomes in all. 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 25 Sep 2024.