S0819: Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer
TerminatedPhase 3Results postedLast updated 23 May 2023
What this trial tests
Phase 3 trial testing Bevacizumab in Recurrent Large Cell Lung Carcinoma in 1,333 participants. Terminated before completion.
Timeline
15 July 2009
Primary endpoint 31 August 2017
8 February 2022
Quick facts
Lead sponsor
SWOG Cancer Research Network
Phase
Phase 3
Status
Terminated
Study type
INTERVENTIONAL
Allocation
randomized
Design
parallel
Masking
none
Primary purpose
treatment
Enrollment
1,333
Start date
15 July 2009
Primary completion
31 August 2017
Estimated completion
8 February 2022
Sites
798 locations across United States, Mexico
Drugs / interventions tested
Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
18 and older, any sex, with Recurrent Large Cell Lung Carcinoma or Recurrent Lung Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Survival (OS) in the Entire Study PopulationPrimary· Patients will be followed every 3 weeks while on protocol treatment. Once off all protocol treatment, patients will be followed every 6 months until death or up to 3 years
From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Group
Value
95% CI
Arm I (Chemo +/- Bevacizumab)
9.2
8.7 – 10.3
Arm II (Chemo, Cetuximab, +/- Bevacizumab)
10.9
9.5 – 12.0
Progression-free Survival (PFS) of EGFR FISH-positive Patients by Institutional ReviewPrimary· Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression.
From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
Arm I (Chemo +/- Bevacizumab)
4.8
3.9 – 5.5
Arm II (Chemo, Cetuximab, +/- Bevacizumab)
5.4
4.5 – 5.7
Overall Survival (OS) of EGFR FISH-positive PatientsSecondary· Patients will be followed every 3 weeks while on protocol treatment. Once off all protocol treatment, patients will be followed every 6 months until death or up to 3 years
From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Group
Value
95% CI
Arm I (Chemo +/- Bevacizumab)
9.8
8.7 – 12.1
Arm II (Chemo, Cetuximab, +/- Bevacizumab)
13.4
11.5 – 14.8
Progression-Free Survival (PFS) of the Entire Study Population by Institutional ReviewSecondary· Disease assessment will be repeated every 6 weeks until disease progression while on treatment. After off treatment, the frequency of disease assessment may be reduced to every 3 months until disease progression.
From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
Arm I (Chemo +/- Bevacizumab)
4.5
4.2 – 5.1
Arm II (Chemo, Cetuximab, +/- Bevacizumab)
4.6
4.2 – 5.2
Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in EGFR FISH-positive PatientsSecondary· Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Group
Value
95% CI
Arm I (Chemo +/- Bevacizumab)
43
36 – 50
Arm II (Chemo, Cetuximab, +/- Bevacizumab)
47
39 – 54
Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in the Entire Study PopulationSecondary· Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Group
Value
95% CI
Arm I (Chemo +/- Bevacizumab)
36
33 – 40
Arm II (Chemo, Cetuximab, +/- Bevacizumab)
42
38 – 46
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsSecondary· Toxicity assessment was evaluated every 3 weeks while one protocol treatment. Chemo and cetuximab is treated for 6 cycles (1 cycle =3 weeks) and Bevacizumab is treated until progression or unacceptable toxicity.
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
ALT, SGPT (serum glutamic pyruvic transaminase)
Group
Value
95% CI
Arm I (Chemo +/- Bevacizumab)
5
Arm II (Chemo, Cetuximab, +/- Bevacizumab)
8
AST, SGOT
Group
Value
95% CI
Arm I (Chemo +/- Bevacizumab)
6
Arm II (Chemo, Cetuximab, +/- Bevacizumab)
8
Acidosis (metabolic or respiratory)
Group
Value
95% CI
Arm I (Chemo +/- Bevacizumab)
0
Arm II (Chemo, Cetuximab, +/- Bevacizumab)
1
Adrenal insufficiency
Group
Value
95% CI
Arm I (Chemo +/- Bevacizumab)
0
Arm II (Chemo, Cetuximab, +/- Bevacizumab)
1
Albumin, serum-low (hypoalbuminemia)
Group
Value
95% CI
Arm I (Chemo +/- Bevacizumab)
8
Arm II (Chemo, Cetuximab, +/- Bevacizumab)
7
Alkaline phosphatase
Group
Value
95% CI
Arm I (Chemo +/- Bevacizumab)
2
Arm II (Chemo, Cetuximab, +/- Bevacizumab)
1
Allergic reaction/hypersensitivity
Group
Value
95% CI
Arm I (Chemo +/- Bevacizumab)
9
Arm II (Chemo, Cetuximab, +/- Bevacizumab)
41
Allergy/Immunology-Other (Specify)
Group
Value
95% CI
Arm I (Chemo +/- Bevacizumab)
0
Arm II (Chemo, Cetuximab, +/- Bevacizumab)
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Toxicity assessment was evaluated every 3 weeks while on protocol treatment. Chemo and cetuximab is treated for 6 cycles (1 cycle =3 weeks) and Bevacizumab is treated until progression, an average of 6 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm I (Chemo +/- Bevacizumab)
Serious: 66/632 (10%)
Deaths: 593/657
Arm II (Chemo, Cetuximab, +/- Bevacizumab)
Serious: 97/627 (15%)
Deaths: 570/656
Serious adverse events (75 terms)
Reaction
System
Arm I (Chemo +/- Bevacizum…
Arm II (Chemo, Cetuximab, …
Death - Disease progression NOS
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This randomized phase III trial studies carboplatin and paclitaxel to compare how well they work with or without bevacizumab and/or cetuximab in treating patients with stage IV or non-small cell lung cancer that has returned after a period of improvement (recurrent). Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may prevent the growth of new blood vessels that tumor needs to grow. Cetuximab may also stop cancer cells from growing by binding and interfering with a protein on the surface of the tumor cell that is needed for tumor growth. It is not yet known whether giving carboplatin and paclitaxel are more effective with or without bevacizumab and/or cetuximab in treating patients with non-small cell lung cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07504588 — Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and
· Phase 2
· not yet recruiting
NCT07500298 — Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable
· Phase 1
· not yet recruiting
NCT07271355 — Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colore
· Phase 3
· not yet recruiting
NCT07318389 — ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer
· EARLY_PHASE1
· not yet recruiting
NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance
· Phase 2
· not yet recruiting
Other SWOG Cancer Research Network trials
Trials by the same sponsor.
NCT07498205 — Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts
· Phase 4
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07278739 — Testing an Educational Program to Improve Goals of Care Conversations Between Patients and Their Care Teams
· NA
· not yet recruiting
NCT06769126 — Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM
· Phase 2
· recruiting
NCT07018869 — Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colore
· Phase 3
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by SWOG Cancer Research Network
Last refreshed: 23 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00946712.