Lung CancerPhase 1/2SCLCNCT00791154

QUILT-2.013: First-Line Treatment for Extensive Stage Small Cell Lung Cancer

A Phase 1/2 study testing AMG 479, Etoposide and AMG 102 in people with Lung Cancer and Small Cell Lung Cancer, run by NantCell, Inc..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This trial is titled "A Phase 1b/2 trial of AMG 479 or AMG 102 with Platinum-Based Chemotherapy as First-Line Treatment for Extensive Stage Small-Cell Lung Cancer (SCLC)." Part 1, the phase 1b portion of this study, is a multicenter, open-label investigation to identify safe dose levels of either AMG 102 or AMG 479 in… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer, Small Cell Lung Cancer, Solid Tumors
What is being tested?: AMG 479, Etoposide and AMG 102
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 213 participants
Where: No sites listed yet
Study dates: 2 Dec 2008to 1 May 2013
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 SCLC
Extensive disease, defined by at least one of the following:
No limited disease (ie, no disease confined to the ipsilateral hemithorax, which can be safely encompassed within a tolerable radiation field)
Extrathoracic metastases
Malignant pericardial or pleural effusion
Contralateral hilar adenopathy

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Measurable or nonmeasurable disease, as defined by modified RECIST
Eastern Cooperative Oncology Group (ECOG) status 0 or 1
≥18 years old
Life expectancy (with therapy) ≥3 months
Adequate hematologic, hepatic, coagulation, renal, and metabolic function
Diabetes, if present, must be controlled, with glycosylated hemoglobin (HbA1C) ≤ 8% and fasting glucose levels ≤160 mg/dL

Who cannot join

Prior chemotherapy, chemoradiation, or investigational agent for SCLC
Prior radiotherapy to >25% of the bone marrow
Symptomatic or untreated central nervous system metastases (with exceptions)
Currently or previously treated with biologic, immunologic or other therapies for SCLC
Current serious or nonhealing wound or ulcer
History of prior concurrent other malignancy (with exceptions)
Thorombosis or vascular ischemic events within the last 12 months such as DVT, PE, TIA or MI
Any clinically significant medical condition other than cancer (eg, cardiovascular disease or COPD), which could interfere with the safe delivery of study treatment or risk of toxicity

About this study

Official title: QUILT-2.013 A Phase 1b/2 Trial of AMG 479 or AMG 102 in Combination With Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

This trial is titled "A Phase 1b/2 trial of AMG 479 or AMG 102 with Platinum-Based Chemotherapy as First-Line Treatment for Extensive Stage Small-Cell Lung Cancer (SCLC)."

Part 1, the phase 1b portion of this study, is a multicenter, open-label investigation to identify safe dose levels of either AMG 102 or AMG 479 in combination with etoposide plus cisplatin or carboplatin in subjects with previously untreated extensive stage SCLC.

Part 2, the phase 2 portion of this study, is a multicenter, double-blind, 3-arm investigation to evaluate overall survival of either AMG 102 or AMG 479 in combination with platinum-based chemotherapy.

Conditions: Lung Cancer, Small Cell Lung Cancer, Solid Tumors, Extensive-stage Small Cell Lung Cancer
Being tested: AMG 479, Etoposide, Placebo, AMG 102, Carboplatin
Keywords: Extensive disease, Extrathoracic metasasis, Malignant pericardial effusion, Malignant pleural effusion, Contralateral hilar adenopathy
Medical subject headings: Lung Neoplasms, Small Cell Lung Carcinoma, Pleural Effusion, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AMG 479Drug
AMG 479 is administered to subjects
EtoposideDrug
Etoposide is administered to subjects
PlaceboDrug
Placebo is administered with Carboplatin and Etoposide
AMG 102Drug
AMG 102 is administered to subjects
CarboplatinDrug
Carboplatin is administered to some subjects in combination
CisplatinDrug
Cisplatin is administered to some subjects in combination

Study groups in NCT00791154
Study group	Role	What they receive
ARM A	Experimental	Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide Receives: Drug: AMG 479; Drug: Etoposide; Drug: Carboplatin; Drug: Cisplatin
ARM B	Experimental	Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide Receives: Drug: Etoposide; Drug: AMG 102; Drug: Carboplatin; Drug: Cisplatin
ARM C	Placebo comparator	Blinded placebo and carboplatin or cisplatin and etoposide Receives: Drug: Etoposide; Drug: Placebo; Drug: Carboplatin; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival in Ganitumab Treated Subjects -Phase 2
The primary efficacy endpoint was overall survival, defined as time from randomization to death from any cause
Measured: Time from randomization to death from any cause, approximately 14 months
Overall Survival in Rilotumumab Treated Subjects-Phase 2
The primary efficacy endpoint is overall survival, defined as time from randomization to death from any cause
Measured: Time from randomization to death from any cause, approximately 14 months
Number of Subjects With Dose Limiting Toxicities-Phase 1
For Part 1, DLTs were defined as the incidence during the first 21 days of starting study treatment of any Grade 3 or higher hematologic or non-hematologic toxicity related to AMG 479 or AMG 102, or the combination of AMG 479 or AMG 102 with chemotherapy, except for lymphocytopenia and anemia. DLTs did not include fatigue, nausea, diarrhea, vomiting, hyperglycemia, neutropenia, thrombocytopenia, increased AST or ALT, or pulmonary embolism unless specific criteria were met as stated in protocol section 6.1.3.2.
Measured: First 21 days after start of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 20081 May 2013

First posted14 Nov 2008 (estimated)
Study start2 Dec 2008
Primary completion2 Feb 2010
Study completion1 May 2013

Why it stopped: Subjects discontinued study

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 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 213 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00791154
Sponsor's protocol ID: QUILT-2.013
Other IDs: NCT00791154
Acronym: SCLC
Status last verified: Aug 2024
First submitted: 23 Oct 2008
Last updated: 23 Aug 2024
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: QUILT-2.013 A Phase 1b/2 Trial of AMG 479 or AMG 102 in Combination With Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00791154
Acronym / sponsor ID: SCLC / QUILT-2.013
Conditions: Lung Cancer, Small Cell Lung Cancer, Solid Tumors, Extensive-stage Small Cell Lung Cancer
Keywords: Extensive disease, Extrathoracic metasasis, Malignant pericardial effusion, Malignant pleural effusion, Contralateral hilar adenopathy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Subjects discontinued study
Enrolment: 213 participants (actual)
Lead sponsor: NantCell, Inc.Industry (pharma, biotech, devices)
Study start: 2 Dec 2008 (actual)
Primary completion: 2 Feb 2010 (actual)
Study completion: 1 May 2013 (actual)
First posted: 14 Nov 2008 (estimated)
Results: Posted 23 Aug 2024

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 titled "A Phase 1b/2 trial of AMG 479 or AMG 102 with Platinum-Based Chemotherapy as First-Line Treatment for Extensive Stage Small-Cell Lung Cancer (SCLC)."

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
ARM A	Experimental	Drug: AMG 479, Drug: Etoposide, Drug: Carboplatin, Drug: CisplatinBlinded AMG 479 study drug and carboplatin or cisplatin and etoposide
ARM B	Experimental	Drug: Etoposide, Drug: AMG 102, Drug: Carboplatin, Drug: CisplatinBlinded AMG 102 study drug and carboplatin or cisplatin and etoposide
ARM C	Placebo comparator	Drug: Etoposide, Drug: Placebo, Drug: Carboplatin, Drug: CisplatinBlinded placebo and carboplatin or cisplatin and etoposide

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Histologically or cytologically confirmed SCLC
Extensive disease, defined by at least one of the following:
No limited disease (ie, no disease confined to the ipsilateral hemithorax, which can be safely encompassed within a tolerable radiation field)
Extrathoracic metastases
Malignant pericardial or pleural effusion

Key exclusion criteria (8 listed)

Prior chemotherapy, chemoradiation, or investigational agent for SCLC
Prior radiotherapy to >25% of the bone marrow
Symptomatic or untreated central nervous system metastases (with exceptions)
Currently or previously treated with biologic, immunologic or other therapies for SCLC
Current serious or nonhealing wound or ulcer

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 is administered to subjects	Drug	ARM A
EtoposideEtoposide is administered to subjects	Drug	ARM A, ARM B, ARM C
PlaceboPlacebo is administered with Carboplatin and Etoposide	Drug	ARM C
AMG 102AMG 102 is administered to subjects	Drug	ARM B
CarboplatinCarboplatin is administered to some subjects in combination	Drug	ARM A, ARM B, ARM C
CisplatinCisplatin is administered to some subjects in combination	Drug	ARM A, ARM B, ARM C

Primary outcome

Overall Survival in Ganitumab Treated Subjects -Phase 2
Time frame: Time from randomization to death from any cause, approximately 14 months
The primary efficacy endpoint was overall survival, defined as time from randomization to death from any cause
Overall Survival in Rilotumumab Treated Subjects-Phase 2
Time frame: Time from randomization to death from any cause, approximately 14 months
The primary efficacy endpoint is overall survival, defined as time from randomization to death from any cause
Number of Subjects With Dose Limiting Toxicities-Phase 1
Time frame: First 21 days after start of study treatment
For Part 1, DLTs were defined as the incidence during the first 21 days of starting study treatment of any Grade 3 or higher hematologic or non-hematologic toxicity related to AMG 479 or AMG 102, or the combination of AMG 479 or AMG 102 with chemotherapy, except for lymphocytopenia and anemia. DLTs did not include fatigue, nausea, diarrhea, vomiting, hyperglycemia, neutropenia, thrombocytopenia, increased AST or ALT, or pulmonary embolism unless specific criteria were met as stated in protocol section 6.1.3.2.

Results and safety

Results posted to the registry on 23 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1: AMG 479/Carboplatin+Etoposide	6	0
Phase 1: AMG 479/Cisplatin+Etoposide	8	0
Phase 1: AMG102/Carboplatin+Etoposide	6	0
Phase 1: AMG 102/Cisplatin+Etoposide	8	0
Phase 2 Ganitumab	62	0
Phase 2 Rilotumumab	62	0
Phase 2 Placebo	61	0

Primary outcome: Overall Survival in Ganitumab Treated Subjects -Phase 2

Time frame: Time from randomization to death from any cause, approximately 14 months. Median (95% Confidence Interval). Unit: months

Measure	Phase 2 Ganitumab n = 62	Phase 2 Placebo n = 61
Value	10.7 (8.1 to 14.1)	10.8 (9.4 to 11.9)

Primary outcome: Overall Survival in Rilotumumab Treated Subjects-Phase 2

Time frame: Time from randomization to death from any cause, approximately 14 months. Median (95% Confidence Interval). Unit: months

Measure	Phase 1: AMG 479/Carboplatin+Etoposide n = 0	Phase 1: AMG 479/Cisplatin+Etoposide n = 0	Phase 1: AMG102/Carboplatin+Etoposide n = 0	Phase 1: AMG 102/Cisplatin+Etoposide n = 0	Phase 2 Rilotumumab n = 62	Phase 2 Placebo n = 61
Value	–	–	–	–	12.2 (8.8 to 14.6)	10.8 (9.4 to 11.9)

Population analysed: This endpoint was phase 2 subjects only

Primary outcome: Number of Subjects With Dose Limiting Toxicities-Phase 1

Time frame: First 21 days after start of study treatment. Count of participants. Unit: Participants

Measure	Phase 1: AMG 479/Carboplatin+Etoposide n = 6	Phase 1: AMG 479/Cisplatin+Etoposide n = 7	Phase 1: AMG102/Carboplatin+Etoposide n = 6	Phase 1: AMG 102/Cisplatin+Etoposide n = 8	Phase 2 Ganitumab n = 0	Phase 2 Rilotumumab n = 0	Phase 2 Placebo n = 0
Value	1	0	0	0	0	0	0

Population analysed: This endpoint is for phase 1 subjects only

Adverse events

Time frame: All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1: AMG 479/Carboplatin+Etoposide	5 of 6 (83.3%)	6 of 6 (100%)	5 of 6
Phase 1: AMG 479/Cisplatin+Etoposide	2 of 7 (28.6%)	6 of 7 (85.7%)	4 of 8
Phase 1: AMG102/Carboplatin+Etoposide	4 of 6 (66.7%)	6 of 6 (100%)	4 of 6
Phase 1: AMG 102/Cisplatin+Etoposide	7 of 8 (87.5%)	8 of 8 (100%)	7 of 8
Phase 2 Ganitumab	7 of 59 (11.9%)	58 of 59 (98.3%)	54 of 62
Phase 2 Rilotumumab	6 of 61 (9.8%)	61 of 61 (100%)	54 of 62
Phase 2 Placebo	3 of 59 (5.1%)	57 of 59 (96.6%)	52 of 61

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AMG 479, Etoposide and AMG 102 in people with Lung Cancer and Small Cell Lung Cancer, run by NantCell, Inc..

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 12 inclusion and 8 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 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 23 Aug 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?

Overall Survival in Ganitumab Treated Subjects -Phase 2 (time frame: Time from randomization to death from any cause, approximately 14 months). The study lists 3 primary outcomes in all. 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 NCT00791154.

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 23 Aug 2024.